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

Model Number	SCRWDRV SFT,SHT NON-CANN,2.5MM HEX
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/17/2022
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 01/20/2022 it was reported by a sales representative via sems that an ar-1995shn was used in implant removal surgery after acl reconstruction on (b)(6) 2021.When the screw was removed, the product was broken, and the broken piece fell off inside the screw.The broken piece and the screw could not be removed and the surgery was completed with the screw left in the body.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1995shn was received for investigation.Visual inspection identified that the distal tip of the drive geometry had sheared off, with the breakage site noticeably twisted.Assessment with digital micrometer id: 224 identified that the driver shaft met design specifications.The probable cause is attributed to over-torquing/over-engaging the driver within the screw head during use.

• Brand Name: SCRWDRV SFT,SHT NON-CANN,2.5MM HEX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13472179
• Report Number: 1220246-2022-04431
• Device Sequence Number: 1763923
• 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): 04/13/2022

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: 01/19/2022
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown