DEPTH GAUGE, 6.5/7.3MM
Report
- Report Number
- 2027754-2023-00074
- Event Type
- Malfunction
- Date Received
- December 13, 2023
- Date of Event
- November 13, 2023
- Report Date
- December 13, 2023
- Manufacturer
- OSTEOMED, LLC
- Product Code
- HWC
- UDI-DI
- 00845694035613
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- 003
Narratives
IT WAS REPORTED THAT THE WIRE IN THE ACCOMPANYING SET, 2.8MM GUIDEWIRE, WOULD NOT FIT THROUGH THE DEPTH GAUGE, 316-0017. THE DEPTH GAUGE WAS RETURNED FOR EVALUATION AND INSPECTION REVEALED A LABORATORY WIRE DID NOT FIT THROUGH THE DEPTH GAUGE, WHICH CONFIRMS THE REPORTED EVENT. THE OPENING WAS MEASURED BY QUALITY CONTROL AND CONFIRMED THERE IS A MISALIGNMENT POTENTIALLY CAUSED DURING WELDING. REVIEW OF THE DHR REVEALED ALL INSPECTIONS PASSED WITH NO ANOMALIES IDENTIFIED. THERE WAS NO REMAINING INVENTORY OF THIS PART NUMBER AND LOT NUMBER FOR REVIEW. A REVIEW OF COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS FOR PART NUMBER 316-0017.
IT WAS REPORTED DURING THE TRIPLE ANKLE ARTHODESIS SURGERY, THE SPECIALIST DECIDES TO PLACE A CANULATED SCREW WITH A 6.5MM HEAD FROM THE CANULATED SET. AT THE TIME OF PLACING THIS SCREW, THE SPECIALIST IMPLANTS A 2.8 GUIDE AND WHEN HE IS GOING TO ENHANCE THE MEASUREMENT WITH THE DEPTH GAUGE (PART NUMBER 316-0017), IT WAS NOTED THE GUIDE DID NOT GO THROUGH THE DEPTH GAUGE. THE SPECIALIST TRIED TO CHANGE GUIDES BUT NONE OF THE GUIDES IN THE SET WENT THROUGH THE DEPTH GAUGE, THE SPECIALIST MEASURED WITH THE HELP OF ANOTHER GUIDE TO COMPLETE THE SURGERY. THIS PROLONGED THE SURGERY BY 35 MINUTES. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1580396 | DEPTH GAUGE, 6.5/7.3MM | SCREW, FIXATION, BONE | HWC | OSTEOMED, LLC | 316-0017 | 1167639 | 00845694035613 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Male |