MITEK BIOKNOTLESS RAPIDE (BR) W/ORTHOCORD
Report
- Report Number
- 1221934-2013-00151
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- May 29, 2013
- Report Date
- May 29, 2013
- Manufacturer
- DEPUY MITEK
- Product Code
- MAI
- PMA / PMN Number
- K070925
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
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.
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
FORTY-ONE DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK; NOTHING IS BEING RETURNED FOR EVALUATION; COMPLAINT DEVICE DISCARDED AT USER FACILITY. NO LOT NUMBER HAS BEEN SUPPLIED, WHICH PRECLUDES CONDUCTING A BATCH RECORD REVIEW TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. THERE WAS ONE YEAR BETWEEN THE SUCCESSFUL PROCEDURE AND THE SUBSEQUENT EVENT IN WHICH THE PATIENT WAS ¿WRESTLING¿; AGAIN, THERE WAS ONE FULL YEAR OF BONE AND SOFT TISSUE HEALING AND THE ADLS WITH THE GENERAL USE OF THE LIMB. OUTSIDE OF THE REPORTED ACTIVITY, WRESTLING, AS THE POSSIBLE UNDERLYING CAUSE FOR THE ISSUE, WE CANNOT DISCERN ANY OTHER ROOT CAUSE FOR THE REPORTED DEVICE¿S FAILURE MODE. 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.
OUR REP. IS REPORTING TO US THAT A PATIENT UNDERWENT A SUCCESSFUL ARTHROSCOPIC SHOULDER REPAIR WITH THE USE OF 2 BIOKNOTLESS ANCHORS, 212711, FOR FIXATION APPROXIMATELY 1 YEAR AGO (SOMETIME IN 2012). SUBSEQUENTLY AT SOME POINT IN TIME, POSSIBLY IN (B)(6) 2013, THE PATIENT PRESENTED WITH PAIN, AND IT WAS SOMEHOW DISCERNED THAT THE FIXATION DEVICES HAD PULLED OUT OF THEIR BONE HOLES; THE PATIENT WAS WRESTLING AND POSSIBLY SOME OVER HEAD MOTION AND OR SOME EXTERNAL ROTATION PRECIPITATED THE PULLOUTS. THE PATIENT UNDERWENT A REVISION SURGERY FOR REMEDY ON (B)(6), WHICH WAS COMPLETED SUCCESSFULLY IN A TIMELY MANNER WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICES DISCARDED AT THE USER FACILITY. ALSO SEE ASSOCIATED MDR 1221934-2013-00152
OUR REP. IS REPORTING TO US THAT A PATIENT UNDERWENT A SUCCESSFUL ARTHROSCOPIC SHOULDER REPAIR WITH THE USE OF 2 BIOKNOTLESS ANCHORS, 212711, FOR FIXATION APPROXIMATELY 1 YEAR AGO (SOMETIME IN 2012). SUBSEQUENTLY AT SOME POINT IN TIME, POSSIBLY IN (B)(6) 2013, THE PATIENT PRESENTED WITH PAIN, AND IT WAS SOMEHOW DISCERNED THAT THE FIXATION DEVICES HAD PULLED OUT OF THEIR BONE HOLES; THE PATIENT WAS WRESTLING AND POSSIBLY SOME OVER HEAD MOTION AND OR SOME EXTERNAL ROTATION PRECIPITATED THE PULLOUTS. THE PATIENT UNDERWENT A REVISION SURGERY FOR REMEDY ON (B)(6), WHICH WAS COMPLETED SUCCESSFULLY IN A TIMELY MANNER WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICES DISCARDED AT THE USER FACILITY. ALSO SEE ASSOCIATED MDR 1221934-2013-00152
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255162 | MITEK BIOKNOTLESS RAPIDE (BR) W/ORTHOCORD | SOFT TISSUE FIXATION DEVICE | MAI | DEPUY MITEK | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |