MAUDE Adverse Event Report: ARTHREX, INC. SCRWDRV SFT,SHT NON-CANN,2.5MM HEX; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SCRWDRV SFT,SHT NON-CANN,2.5MM HEX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
On (b)(6) 2023, it was reported by an arthrex employee via sems that an ar-1995shn noncannulated short screwdriver shaft had an issue.The tip of the shaft broke while removing the post screw from the knee.The broken fragment could not be removed.This occurred during use in an unspecified procedure on (b)(6) 2023 with no patient harm.Additional information has been requested.On (b)(6) 2023, the arthrex employee provided the following information via email: this occurred during an acl reconstruction procedure.The tip of the shaft broke inside the patient's knee, and the fragment could not be removed.The surgical procedure was completed successfully, and there was no case delay reported.
Event or Problem Description
On (b)(6) 2023, the arthrex subsidiary employee provided the following information: this procedure was a revision surgery, but no additional information was available regarding the exact date of the first surgery or whether arthrex products were used.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-1995shn was received for investigation.Functional testing was not conducted due to the damage to the broken device into two pieces.Visual evaluation found that the device was broken into two pieces, also the tip of the device was twisted.The most likely cause for the reported failure is user error for applying excessive force during use or through leveraging/prying the device.

• Brand Name: SCRWDRV SFT,SHT NON-CANN,2.5MM HEX
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17754387
• Report Number: 1220246-2023-07905
• Device Sequence Number: 7257138
• Product Code: LXH
• UDI-Device Identifier: 00888867025684
• UDI-Public: 00888867025684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCRWDRV SFT,SHT NON-CANN,2.5MM HEX
• Device Catalogue Number: AR-1995SHN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown