FDA Adverse Event
Malfunction
Summary report: N
LOBSTER CLAMP, RADIOLUCENT
MDR report key: 13087978
·
Received December 27, 2021
Report
- Report Number
- 1220246-2021-04213
- Event Type
- Malfunction
- Date Received
- December 27, 2021
- Date of Event
- December 6, 2021
- Report Date
- January 20, 2022
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867317987
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 0
COMPLAINT CONFIRMED, THE PICTURE SHOWS THE DEVICE IS DISASSEMBLED. THE CAUSE OF THE EVENT IS UNDETERMINED, HOWEVER A LIKELY CAUSE IS USER-APPLIED MECHANICAL FORCES.
Description of Event or Problem · 0
ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT A AR-18700-49 CLAMP, AND A AR-18700-25 SLEEVE ARE BROKEN. THIS OCCURRED ON (B)(6) 2021 DURING A PROCEDURE. THERE WAS NO PATIENT EFFECT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1988833 | LOBSTER CLAMP, RADIOLUCENT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | ARTHREX, INC. | LOBSTER CLAMP, RADIOLUCENT | 34801932 | 00888867317987 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |