FDA Adverse Event
Malfunction
Summary report: N
DYNANITE¿ STAPLE DRL BT, CAL, 1.6, REUSE
MDR report key: 19165145
·
Received April 23, 2024
Report
- Report Number
- 1220246-2024-02253
- Event Type
- Malfunction
- Date Received
- April 23, 2024
- Date of Event
- April 20, 2021
- Report Date
- April 23, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- HTW
- UDI-DI
- 00888867326163
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT CONFIRMED. VISUAL INSPECTION IDENTIFIED THAT THE DRILL BIT SHAFT HAS BROKEN OFF AND TIP IS STUCK INSIDE THE RETURNED DRILL GUIDE. A LIKELY CAUSE OF THE EVENT IS PRYING/LEVERAGING THE MATING DRILL BIT DURING USE.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A CASE, WHEN DRILLING WITH THE AR-8717D-01-RU, THE DRILL LOCKED IN THE AR-8717G-01 PARALLEL GUIDE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1189476 | DYNANITE¿ STAPLE DRL BT, CAL, 1.6, REUSE | DRILL BIT | HTW | ARTHREX, INC. | DYNANITE¿ STAPLE DRL BT, CAL, 1.6, REUSE | 031938 | 00888867326163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |