FDA Adverse Event
Malfunction
Summary report: Y
ELITE 7CM STRAIGHT ATTACHMENT
MDR report key: 21201171
·
Received January 21, 2025
Report
- Report Number
- 3015967359-2025-00257
- Event Type
- Malfunction
- Date Received
- January 21, 2025
- Date of Event
- December 31, 2024
- Report Date
- January 21, 2025
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- HBE
- UDI-DI
- 07613327096545
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS 74 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 74 DEVICES WERE EVALUATED BASED ON HISTORICAL DATA ANALYSIS. ADDITIONAL INFORMATION 74 DEVICES WERE NOT LABELED FOR SINGLE-USE. 74 DEVICES WERE NOT REPROCESSED OR REUSED.
Description of Event or Problem · 0
THIS REPORT SUMMARIZES 74 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. - 46 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 2 EVENTS HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT. - 26 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 858862 | ELITE 7CM STRAIGHT ATTACHMENT | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP | 07613327096545 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |