RECONSTRUCTION PLATE, STRAIGHT HOLES 7 LENGTH 84MM FOR SCREWS Ø3.5/4.0MM
Report
- Report Number
- 0008031020-2014-00465
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- August 31, 2014
- Report Date
- September 15, 2014
- Manufacturer
- STRYKER TRAUMA SELZACH
- Product Code
- HRS
- PMA / PMN Number
- K000636
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.
EVALUATION SUMMARY: THE DEVICE HAS BEEN EXPLANTED BUT NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. BASED ON EVENT DESCRIPTION AND FURTHER INFORMATION RECEIVED (PICTURES OF THE EXPLANTED DEVICE) THE PLATE APPEARS TO BE BENT IN THE MIDDLE OF THE PLATE, PROBABLY RIGHT OVER THE PATIENT FRACTURE LINE. NO X-RAY ARE AVAILABLE TO CONFIRM THIS ASSUMPTION. IT IS NOT CONFIRMED THAT THE PLATE WAS ANATOMICALLY ADJUSTED OR IF BENDING WAS APPEARING DUE TO MECHANICAL STRAIN (OVER LOAD). ADDITIONALLY, AS PER EVENT DESCRIPTION, THE PLATE HAS BEEN USED FOR A RADIUS FRACTURE. AS PER INDICATIONS STATED IN THE OPERATIVE TECHNIQUE (SEE ORIGINAL STATEMENT) THE RECONSTRUCTION PLATE IS TYPICALLY DESIGNED TO BE USED IN SITUATION WHERE STRONG BENDING STRAIN IS NECESSARY (I.E.: DISTAL HUMERUS FRACTURE AND PELVIS). FOR FRACTURES OF THE RADIUS A STIFF COMPRESSION PLATE IS INDICATED.(SEE ORIGINAL INDICATIONS FOR USE IN THE OPERATIVE TECHNIQUE). ACCORDING TO THE AFOREMENTIONED CONSIDERATIONS IT APPEAR THAT THE ROOT CAUSE IS MOST LIKELY DEVICE UNRELATED INDICATIONS CRITERIA ISSUES (IMPROPER DEVICE CHOICE FOR SPECIFIC ANATOMICAL SITUATION ) HOWEVER MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. [ORIGINAL STATEMENTS]: OPERATIVE TECHNIQUE FOR THE RECONTRUCTION PLATE LTSFST REV. 1: INDICATIONS: IMPLANTS OF THE SPS SMALL FRAGMENT SET ARE INDICATED FOR FRACTURES IN THE FOLLOWING AREAS: CLOVERLEAF PLATE FRACTURES OF THE DISTAL TIBIA AND PROXIMAL HUMERUS COMPRESSION PLATES FRACTURES OF THE RADIUS, ULNA, DISTAL TIBIA, FIBULA, DISTAL HUMERUS AND CLAVICLE T-PLATE FRACTURES OF THE DISTAL RADIUS, CALCANEUS AND LATERAL CLAVICLE RECONSTRUCTION PLATE FRACTURES OF THE DISTAL HUMERUS AND PELVIS CALCANEAL PLATE FRACTURES OF THE CALCANEUS ONE-THIRD TUBULAR PLATE FRACTURES OF THE FIBULA, METATARSALS AND METACARPALS CALCANEAL PLATE FRACTURES OF THE CALCANEUS IFUS V15013/J XX/11: " IMPORTANT INFORMATION FOR DOCTORS AND OR STAFF THIS PACKAGE INSERT DOES NOT INCLUDE ALL OF THE INFORMATION NECESSARY FOR SELECTION AND USE OF A DEVICE. PLEASE SEE FULL LABELLING FOR ALL NECESSARY INFORMATION! ENSURE THAT YOU ARE FAMILIAR WITH THE INTENDED USES, INDICATIONS/ CONTRAINDICATIONS, COMPATIBILITY AND CORRECT HANDLING OF THE IMPLANT, WHICH ARE DESCRIBED IN THE OPERATIVE TECHNIQUE MANUAL FOR THE PRODUCT SYSTEM. PLEASE REMEMBER THAT PRODUCT SYSTEMS MAY BE SUBJECT TO ALTERATIONS THAT AFFECT THE COMPATIBILITY OF THE IMPLANT WITH OTHER IMPLANTS OR WITH INSTRUMENTS. FOR YOUR INFORMATION, AVAIL YOURSELF OF THE TRAINING COURSES AND PUBLICATIONS OFFERED. CONTRAINDICATIONS THE PHYSICIAN¿S EDUCATION, TRAINING AND PROFESSIONAL JUDGEMENT MUST BE RELIED UPON TO CHOOSE THE MOST APPROPRIATE DEVICE AND TREATMENT. WARNINGS AND PRECAUTIONS WARNING IMPLANT SELECTION AND SIZING: THE CORRECT SELECTION OF THE FRACTURE FIXATION APPLIANCE IS EXTREMELY IMPORTANT. FAILURE TO USE THE APPROPRIATE APPLIANCE FOR THE FRACTURE CONDITION MAY ACCELERATE CLINICAL FAILURE. FAILURE TO USE THE PROPER COMPONENT TO MAINTAIN ADEQUATE BLOOD SUPPLY AND PROVIDE RIGID FIXATION MAY RESULT IN LOOSENING, BENDING, CRACKING OR FRACTURE OF THE DEVICE AND/OR BONE. THE CORRECT IMPLANT SIZE FOR A GIVEN PATIENT CAN BE DETERMINED BY EVALUATING THE PATIENT¿S HEIGHT, WEIGHT, FUNCTIONAL DEMANDS AND ANATOMY. EVERY IMPLANT MUST BE USED IN THE CORRECT ANATOMIC LOCATION, CONSISTENT WITH ACCEPTED STANDARDS OF INTERNAL FIXATION. "
EVALUATION SUMMARY: THE REPORTED EVENT OF THE BENT PLATE COULD BE CONFIRMED. DEVICE INVESTIGATION ON THE RECEIVED DEVICE SHOWS THAT THE PLATE HAS BEEN SLIGHTLY TWISTED AND BENT IN THE MIDDLE OF THE PLATE DUE TO EXCESSIVE MECHANICAL STRAIN (OVERLOAD) PROBABLY RIGHT OVER THE PATIENT FRACTURE LINE. HOWEVER NO X-RAYS ARE AVAILABLE. THE MATERIAL DEFORMATION MAY HAVE OCCURRED PRE-OPERATIVELY DURING CONTOURING OR WHILST THE DEVICE WAS IMPLANTED. SURFACE DAMAGES (SCRATCHES,MARKS) HAVE BEEN FOUND HOWEVER THESE DAMAGE ARE LIKELY RELATED TO THE EXPLANTATION SURGERY. ADDITIONALLY, AS PER EVENT DESCRIPTION, THE PLATE HAS BEEN USED FOR A RADIUS FRACTURE. AS PER INDICATIONS STATED IN THE OPERATIVE TECHNIQUE (SEE ORIGINAL STATEMENT) THE RECONSTRUCTION PLATE IS TYPICALLY DESIGNED TO BE USED IN SITUATION WHERE STRONG BENDING STRAIN IS NECESSARY (I.E: DISTAL HUMERUS FRACTURE AND PELVIS). FOR FRACTURES OF THE RADIUS A STIFF COMPRESSION PLATE IS INDICATED.(SEE ORIGINAL INDICATIONS FOR USE IN THE OPERATIVE TECHNIQUE). ACCORDING TO THE AFOREMENTIONED CONSIDERATIONS AND INVESTIGATION THE ROOT CAUSE TO THE BENT PLATE WAS ATTRIBUTED TO A USER RELATED ISSUE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. [ORIGINAL STATEMENTS]: OPERATIVE TECHNIQUE FOR THE RECONTRUCTION PLATE LTSFST REV. 1:"INDICATIONS: IMPLANTS OF THE SPS SMALL FRAGMENT SET ARE INDICATED FOR FRACTURES IN THE FOLLOWING AREAS: CLOVERLEAF PLATE FRACTURES OF THE DISTAL TIBIA AND PROXIMAL HUMERUS COMPRESSION PLATES FRACTURES OF THE RADIUS, ULNA, DISTAL TIBIA, FIBULA, DISTAL HUMERUS AND CLAVICLE T-PLATE FRACTURES OF THE DISTAL RADIUS, CALCANEUS AND LATERAL CLAVICLE RECONSTRUCTION PLATE FRACTURES OF THE DISTAL HUMERUS AND PELVIS CALCANEAL PLATE FRACTURES OF THE CALCANEUS ONE-THIRD TUBULAR PLATE FRACTURES OF THE FIBULA, METATARSALS AND METACARPALS CALCANEAL PLATE FRACTURES OF THE CALCANEUS IFUS V15013/J XX/11: "IMPORTANT INFORMATION FOR DOCTORS AND OR STAFF THIS PACKAGE INSERT DOES NOT INCLUDE ALL OF THE INFORMATION NECESSARY FOR SELECTION AND USE OF A DEVICE. PLEASE SEE FULL LABELLING FOR ALL NECESSARY INFORMATION! ENSURE THAT YOU ARE FAMILIAR WITH THE INTENDED USES, INDICATIONS/ CONTRAINDICATIONS, COMPATIBILITY AND CORRECT HANDLING OF THE IMPLANT, WHICH ARE DESCRIBED IN THE OPERATIVE TECHNIQUE MANUAL FOR THE PRODUCT SYSTEM. PLEASE REMEMBER THAT PRODUCT SYSTEMS MAY BE SUBJECT TO ALTERATIONS THAT AFFECT THE COMPATIBILITY OF THE IMPLANT WITH OTHER IMPLANTS OR WITH INSTRUMENTS. FOR YOUR INFORMATION, AVAIL YOURSELF OF THE TRAINING COURSES AND PUBLICATIONS OFFERED. CONTRAINDICATIONS THE PHYSICIAN¿S EDUCATION, TRAINING AND PROFESSIONAL JUDGEMENT MUST BE RELIED UPON TO CHOOSE THE MOST APPROPRIATE DEVICE AND TREATMENT. WARNINGS AND PRECAUTIONS WARNING IMPLANT SELECTION AND SIZING: THE CORRECT SELECTION OF THE FRACTURE FIXATION APPLIANCE IS EXTREMELY IMPORTANT. FAILURE TO USE THE APPROPRIATE APPLIANCE FOR THE FRACTURE CONDITION MAY ACCELERATE CLINICAL FAILURE. FAILURE TO USE THE PROPER COMPONENT TO MAINTAIN ADEQUATE BLOOD SUPPLY AND PROVIDE RIGID FIXATION MAY RESULT IN LOOSENING, BENDING, CRACKING OR FRACTURE OF THE DEVICE AND/OR BONE. THE CORRECT IMPLANT SIZE FOR A GIVEN PATIENT CAN BE DETERMINED BY EVALUATING THE PATIENT¿S HEIGHT, WEIGHT, FUNCTIONAL DEMANDS AND ANATOMY. EVERY IMPLANT MUST BE USED IN THE CORRECT ANATOMIC LOCATION, CONSISTENT WITH ACCEPTED STANDARDS OF INTERNAL FIXATION. "
IN THE BEGINNING OF (B)(6), THE PATIENT HAD A PLATE IMPLANTED FOR A BROKEN RADIUS. X RAYS CONFIRMED CORRECT PLACEMENT OF THE PLATE. PATIENT WAS TREATED WITH PLASTER. AFTER 40 DAYS, X RAYS SHOWED THAT THE PLATE WAS BENT.
IN THE BEGINNING OF (B)(6), THE PATIENT HAD A PLATE IMPLANTED FOR A BROKEN RADIUS. X RAYS CONFIRMED CORRECT PLACEMENT OF THE PLATE. PATIENT WAS TREATED WITH PLASTER. AFTER 40 DAYS, X RAYS SHOWED THAT THE PLATE WAS BENT.
IN THE BEGINNING OF AUGUST, THE PATIENT HAD A PLATE IMPLANTED FOR A BROKEN RADIUS. X RAYS CONFIRMED CORRECT PLACEMENT OF THE PLATE. PATIENT WAS TREATED WITH PLASTER. AFTER 40 DAYS, X RAYS SHOWED THAT THE PLATE WAS BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611253 | RECONSTRUCTION PLATE, STRAIGHT HOLES 7 LENGTH 84MM FOR SCREWS Ø3.5/4.0MM | PLATE, FIXATION, BONE | HRS | STRYKER TRAUMA SELZACH | W21220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |