ELITE 14CM ANGLED ATTACHMENT
Report
- Report Number
- 0001811755-2019-02486
- Event Type
- Malfunction
- Date Received
- July 23, 2019
- Date of Event
- June 24, 2019
- Report Date
- July 29, 2020
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- UDI-DI
- 07613327096590
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE. 54 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 50 DEVICES WERE RECEIVED. 3 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS 21 REPORTED EVENTS WERE CONFIRMED. 29 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 12 DEVICES WERE FOUND TO BE AFFECTED BY CORROSION. 32 DEVICES WERE FOUND TO BE AFFECTED BY COMPROMISED LUBRICATION. 4 DEVICES WERE FOUND TO BE AFFECTED BY DAMAGED BEARINGS. 1 DEVICE WAS FOUND TO BE AFFECTED BY A DAMAGED DRIVESHAFT. 1 DEVICE HAD NO PROBLEM FOUND.
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE 54 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING PERIOD; HOWEVER, - 1 PREVIOUSLY REPORTED EVENT IN THIS REPORT SHOULD HAVE BEEN INCLUDED UNDER MFR REPORT # 0001811755-2019-02411. - 53 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 49 DEVICES WERE RECEIVED. 3 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS 21 REPORTED EVENTS WERE CONFIRMED. 28 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 4 DEVICES WERE FOUND TO BE AFFECTED BY DAMAGED BEARINGS. 32 DEVICES WERE FOUND TO BE AFFECTED BY BROKEN DOWN LUBRICATION. 12 DEVICES WERE FOUND TO BE AFFECTED BY INTERNAL CORROSION. 1 DEVICE WAS FOUND TO BE AFFECTED BY A DAMAGED DRIVESHAFT.
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE CORRECTED DATA: H10, B5 54 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 51 DEVICES WERE RECEIVED. 3 DEVICES WERE NOT AVAILABLE FOR EVALUATION. EVENT CONFIRMATION STATUS 21 REPORTED EVENTS WERE CONFIRMED. 30 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 12 DEVICES WERE FOUND TO BE AFFECTED BY CORROSION. 32 DEVICES WERE FOUND TO BE AFFECTED BY COMPROMISED LUBRICATION. 4 DEVICES WERE FOUND TO BE AFFECTED BY DAMAGED BEARINGS. 1 DEVICE WAS FOUND TO BE AFFECTED BY A DAMAGED DRIVESHAFT. 2 DEVICES HAD NO PROBLEM FOUND.
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE CORRECTED DATA: 53 EVENTS WERE PREVIOUSLY REPORTED DURING THE REPORTING QUARTER; HOWEVER: - 1 PREVIOUSLY REPORTED EVENT WAS INCLUDED UNDER MFR REPORT # 0001811755-2019-02411 BUT SHOULD BE INCLUDED UNDER THIS REPORT. - 54 TOTAL EVENTS WERE REPORTED FOR THIS CATALOG NUMBER/DEVICE CODE COMBINATION FOR THE REPORTING QUARTER. - 54 PREVIOUSLY REPORTED EVENTS ARE INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 49 DEVICES WERE RECEIVED. 3 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 2 DEVICE INVESTIGATION TYPES HAVE NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS 21 REPORTED EVENTS WERE CONFIRMED. 28 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS 4 DEVICES WERE FOUND TO BE AFFECTED BY DAMAGED BEARINGS. 32 DEVICES WERE FOUND TO BE AFFECTED BY BROKEN DOWN LUBRICATION. 12 DEVICES WERE FOUND TO BE AFFECTED BY INTERNAL CORROSION. 1 DEVICE WAS FOUND TO BE AFFECTED BY A DAMAGED DRIVESHAFT.
THIS REPORT SUMMARIZES <NOE> 54 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 49 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 5 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
THIS REPORT SUMMARIZES <NOE> 53 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 48 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 5 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
THIS REPORT SUMMARIZES <NOE> 54 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 48 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 6 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
THIS REPORT SUMMARIZES <NOE> 54 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 49 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 5 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 54 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 48 DEVICES WERE RECEIVED. 3 DEVICES WERE NOT AVAILABLE FOR EVALUATION. 3 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. EVENT CONFIRMATION STATUS: 21 REPORTED EVENTS WERE CONFIRMED. 27 REPORTED EVENTS WERE NOT CONFIRMED. EVALUATION RESULTS: 25 DEVICES WERE FOUND TO BE AFFECTED BY INTERNAL CORROSION. 18 DEVICES WERE FOUND TO BE AFFECTED BY COMPROMISED LUBRICATION. 5 DEVICES WERE FOUND TO BE AFFECTED BY DAMAGED BEARINGS. ADDITIONAL INFORMATION: 54 DEVICES WERE NOT LABELED FOR SINGLE-USE. 54 DEVICES WERE NOT REPROCESSED AND REUSED.
THIS REPORT SUMMARIZES 54 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 49 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. 5 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 609733 | ELITE 14CM ANGLED ATTACHMENT | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO | 5407-120-482 | 07613327096590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |