OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 8X8X8MM
Report
- Report Number
- 0008031020-2016-00534
- Event Type
- Injury
- Date Received
- November 2, 2016
- Date of Event
- October 5, 2016
- Report Date
- June 20, 2017
- Manufacturer
- STRYKER GMBH
- Product Code
- JDR
- PMA / PMN Number
- K070031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
THE REPORTED EVENT THAT OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 8X8X8MM WAS ALLEGED OF 'POOR FIXATION' COULD NOT BE CONFIRMED, SINCE THE RETURNED DEVICE IS CONFORMING TO SPECIFICATIONS AND NO OTHER EVIDENCES WERE PROVIDED (E.G. X-RAYS). MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE STRYKER IMPLANT HAS BEEN DELIVERED IN STERILE CONDITION A RESPECTIVE STATEMENT CONCERNING CONTAMINATION OF STERILE STRYKER DEVICES IS ATTACHED. IN THE CASE OF A CLINICALLY MANIFEST INFECTION, IN WHICH ANY STERILE PACKED STRYKER DEVICE WAS INVOLVED, DQF 13-003 SHALL BE FILLED BY THE HOSPITAL (OR EXCEPTIONALLY BY THE SALES REP) DUE TO FORMAL REASONS. IF THERE ARE NO OBVIOUS EVENTS, WHICH MAY BE CAUSED IN THE FIELD OF RESPONSIBILITY OF STRYKER, STRYKER SHALL DECLINE ALL RESPONSIBILITY IN GENERAL BECAUSE THE PROBABILITY THAT A CONTAMINATION OF THE STERILE PACKED DEVICES HAS BEEN CAUSED IN STRYKER¿S SPHERE OF INFLUENCE IS NEGLIGIBLE. DESPITE SEVERAL ATTEMPTS WITH THE SALES REP, THE CUSTOMER AND THE HOSPITAL, WE NEVER RECEIVED ANY FEEDBACK NOR THE POPULATED DQF 13-003. HOWEVER, MANUFACTURING AND STERILIZATION DOCUMENTS HAVE BEEN REVIEWED: NO DEVIATION WAS DETECTED. IN ADDITION, DEVICE INSPECTION DOES NOT SHOW ANYTHING UNUSUAL: DIMENSIONAL AND FUNCTIONAL INSPECTIONS HAVE BEEN DONE AND EVERYTHING WAS CONFORMED, NO DEVIATION HAS BEEN NOTICED AND THE SUPERELASTIC MEMORY SHAPE EFFECT IS EFFECTIVE AND CONFORM. 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 INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.
THE REPORTED EVENT THAT OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 8X8X8MM WAS ALLEGED OF 'POOR FIXATION' COULD NOT BE CONFIRMED, SINCE THE RETURNED DEVICE IS CONFORMING TO SPECIFICATIONS AND NO OTHER EVIDENCES WERE PROVIDED (E.G. X-RAYS). MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE STRYKER IMPLANT HAS BEEN DELIVERED IN STERILE CONDITION A RESPECTIVE STATEMENT CONCERNING CONTAMINATION OF STERILE STRYKER DEVICES IS ATTACHED. IN THE CASE OF A CLINICALLY MANIFEST INFECTION, IN WHICH ANY STERILE PACKED STRYKER DEVICE WAS INVOLVED, DQF 13-003 SHALL BE FILLED BY THE HOSPITAL (OR EXCEPTIONALLY BY THE SALES REP) DUE TO FORMAL REASONS. IF THERE ARE NO OBVIOUS EVENTS, WHICH MAY BE CAUSED IN THE FIELD OF RESPONSIBILITY OF STRYKER, STRYKER SHALL DECLINE ALL RESPONSIBILITY IN GENERAL BECAUSE THE PROBABILITY THAT A CONTAMINATION OF THE STERILE PACKED DEVICES HAS BEEN CAUSED IN STRYKER¿S SPHERE OF INFLUENCE IS NEGLIGIBLE. DESPITE SEVERAL ATTEMPTS WITH THE SALES REP, THE CUSTOMER AND THE HOSPITAL, WE NEVER RECEIVED ANY FEEDBACK NOR THE POPULATED DQF 13-003. HOWEVER, MANUFACTURING AND STERILIZATION DOCUMENTS HAVE BEEN REVIEWED: NO DEVIATION WAS DETECTED. IN ADDITION, DEVICE INSPECTION DOES NOT SHOW ANYTHING UNUSUAL: DIMENSIONAL AND FUNCTIONAL INSPECTIONS HAVE BEEN DONE AND EVERYTHING WAS CONFORMED, NO DEVIATION HAS BEEN NOTICED AND THE SUPERELASTIC MEMORY SHAPE EFFECT IS EFFECTIVE AND CONFORM. 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 INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.
IT WAS REPORTED THAT THE EASY CLIP STAPLE WAS IMPLANTED (B)(6) 2015 FOR RIGHT D2 FUSION. THE PATIENT ALLEGEDLY HAD SWELLING AND EVENTUAL INFECTION AT THE OPERATIVE SITE. THE STAPLE WAS REPORTED TO HAVE BACKED OUT OF THE FINGER AND EVENTUALLY STARTED TO COME THROUGH SKIN, WHERE THE STAPLE WAS REPORTED TO BE EXPLANTED UNDER LOCAL ANAESTHESIA ON OCTOBER 5. .
IT WAS REPORTED THAT THE EASY CLIP STAPLE WAS IMPLANTED (B)(6) 2015 FOR RIGHT D2 FUSION. THE PATIENT ALLEGEDLY HAD SWELLING AND EVENTUAL INFECTION AT THE OPERATIVE SITE. THE STAPLE WAS REPORTED TO HAVE BACKED OUT OF THE FINGER AND EVENTUALLY STARTED TO COME THROUGH SKIN, WHERE THE STAPLE WAS REPORTED TO BE EXPLANTED UNDER LOCAL ANAESTHESIA ON OCTOBER 5. .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723503 | OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 8X8X8MM | SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES. | JDR | STRYKER GMBH | F005680PDBU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |