1.5MM HEX, CMP FT
Report
- Report Number
- 1220246-2021-04109
- Event Type
- Malfunction
- Date Received
- December 13, 2021
- Date of Event
- November 22, 2021
- Report Date
- December 13, 2021
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867127159
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- 501
Narratives
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.
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.
ON 11/24/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT A AR-8737-37 SHAFT TIP BROKE OFF, AND A AR-8737-61 SCREW REMOVER TIP BROKE. THIS OCCURRED ON (B)(6) 2021 DURING A METACARPAL FRACTURE WHILE INSERTING THE 2.5MMX50MM INTO THE 4TH METACARPAL THE CANAL OF THE METACARPAL IT WAS VERY TIGHT. THE METACARPAL WAS PREPARED WITH THE CORRECT CORRESPONDING DRILL BIT FOR THE 2.5MM HEADLESS COMPRESSION FT SCREW. WHILE INSERTING THE SCREW THE CANNULATED SCREW DRIVER TIP (AR-8737-37) BROKE OFF AND WAS THEN REMOVED. THE SURGEON THEN PROCEEDED TO USE THE SOLID SCREW DRIVER IN THE SET TO CONTINUE INSERTING THE SCREW. THE SCREW BECAME TIGHT IN THE SHAFT OF THE 4TH METACARPAL AND OF THE APPROXIMATELY 4MM OF THE SCREW BROKE. THE HEADLESS, BROKEN PORTION OF THE SCREW WAS REMOVED. THE SURGEON CONTINUE USING THE CORRESPONDING EASY OUT (AR-8737-61) TO TRY AND REMOVE THE PORTION OF THE SCREW THAT WAS STILL IN THE 4TH METACARPAL, AND THE EASY OUT TIP BROKE UPON TRYING TO REMOVE THE SCREW AND THE SMALL PORTION OF THE TIP WAS LEFT INSIDE OF THE CANNULATED PORTION OF THE SCREW. THE SCREW WAS LEFT IN THE 4TH METACARPAL AS COMPRESSION ACROSS THE FRACTURE SITE WAS ACHIEVED. THE SCREW REMAINS IN THE PATIENT
ON 11/24/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT A AR-8737-37 SHAFT TIP BROKE OFF, AND A AR-8737-61 SCREW REMOVER TIP BROKE. THIS OCCURRED ON (B)(6) 2021 DURING A METACARPAL FRACTURE WHILE INSERTING THE 2.5MMX50MM INTO THE 4TH METACARPAL THE CANAL OF THE METACARPAL IT WAS VERY TIGHT. THE METACARPAL WAS PREPARED WITH THE CORRECT CORRESPONDING DRILL BIT FOR THE 2.5MM HEADLESS COMPRESSION FT SCREW. WHILE INSERTING THE SCREW THE CANNULATED SCREW DRIVER TIP (AR-8737-37) BROKE OFF AND WAS THEN REMOVED. THE SURGEON THEN PROCEEDED TO USE THE SOLID SCREW DRIVER IN THE SET TO CONTINUE INSERTING THE SCREW. THE SCREW BECAME TIGHT IN THE SHAFT OF THE 4TH METACARPAL AND OF THE APPROXIMATELY 4MM OF THE SCREW BROKE. THE HEADLESS, BROKEN PORTION OF THE SCREW WAS REMOVED. THE SURGEON CONTINUE USING THE CORRESPONDING EASY OUT (AR-8737-61) TO TRY AND REMOVE THE PORTION OF THE SCREW THAT WAS STILL IN THE 4TH METACARPAL, AND THE EASY OUT TIP BROKE UPON TRYING TO REMOVE THE SCREW AND THE SMALL PORTION OF THE TIP WAS LEFT INSIDE OF THE CANNULATED PORTION OF THE SCREW. THE SCREW WAS LEFT IN THE 4TH METACARPAL AS COMPRESSION ACROSS THE FRACTURE SITE WAS ACHIEVED. THE SCREW REMAINS IN THE PATIENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1890026 | 1.5MM HEX, CMP FT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | ARTHREX, INC. | 1.5MM HEX, CMP FT | 00888867127159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |