MITEK BIOKNOTLESS RAPIDE (BR) W/PANACRYL
Report
- Report Number
- 1221934-2013-00139
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- April 24, 2013
- Report Date
- April 24, 2013
- Manufacturer
- DEPUY MITEK
- Product Code
- MAI
- PMA / PMN Number
- K070925
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
WE RECEIVED TWO COMPLAINT DEVICES, WHICH WERE VISUALLY EVALUATED, BOTH WITH THE NAKED EYE AND UNDER MAGNIFICATION. THE COMPLAINT STATES THAT A PORTION OF THE DISTAL TIPS OF 2 INSERTERS BROKE OFF DURING THE SURGERY; HOWEVER, ONLY 1 OF THE 2 DEVICES ARE IN THAT CONDITION. IN OTHER WORDS, 1 DEVICE HAS A PORTION OF ITS DISTAL TIP BROKEN AND THE OTHER IS INTACT, NO DAMAGE AND NO ANOMALIES. BOTH DEVICES ARE OF THE SAME LOT: A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT, OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT TELL ANYTHING FROM THIS; OUTSIDE OF THE FOLLOWING HYPOTHESIS WE CANNOT DISCERN ANY OTHER ROOT FOR THE REPORTED ISSUE: THIS TYPE OF FAILURE HAS HISTORICALLY BEEN ATTRIBUTED TO USER TECHNIQUE. FROM AN ENGINEERING PERSPECTIVE, DAMAGE TO THE INSERTER, ¿TIP BREAKAGE¿ OR ¿SHAFT BENDING¿, MAY HAVE BEEN CAUSED BY OFF-ANGLE OR OFF AXIS INSERTION INTO THE BONE HOLE. OFF ANGLE/AXIS INSERTION IS THE MOST LIKELY CAUSE FOR THE INSERTER DISTAL TIP FAILURE, USUALLY THE RESULT OF BENDING AND/OR TWISTING THE ANCHOR DURING DEPLOYMENT DUE TO ANCHOR / BONE HOLE MISALIGNMENT. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.
MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT. AWAITING RETURN.
MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT. AWAITING RETURN.
OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE A PORTION OF THE DISTAL TIPS OF TWO BIOKNOTLESS INSERTER DEVICES BROKE OFF INTO THEIR ANCHORS WHILST THE SURGEON WAS DEPLOYING THE ANCHORS INTO THE BONE HOLES. THE FRAGMENTS REMAIN IN THE ANCHORS WHICH ARE SECURED INTO THE BONE HOLES. THE COMPLETED THE REPAIR WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.
OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE A PORTION OF THE DISTAL TIPS OF TWO BIOKNOTLESS INSERTER DEVICES BROKE OFF INTO THEIR ANCHORS WHILST THE SURGEON WAS DEPLOYING THE ANCHORS INTO THE BONE HOLES. THE FRAGMENTS REMAIN IN THE ANCHORS WHICH ARE SECURED INTO THE BONE HOLES. THE COMPLETED THE REPAIR WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. ALSO SEE ASSOCIATED MDR 1221934-2013-00141.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224986 | MITEK BIOKNOTLESS RAPIDE (BR) W/PANACRYL | SOFT TISSUE FIXATION DEVICE | MAI | DEPUY MITEK | NA | 3646473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |