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	Insufficient Information (4580)
Date of Event	09/16/2022
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 (b)(6) 2022, it was reported by an arthrex employee via sems that an ar-1995shn driver broke after screw insertion during an acl reconstruction.The broken piece of the driver was retained within the screw and could not be removed.Adequate fixation was achieved with no change in surgical technique or additional product needed.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection it was noted that the drive geometry at the distal tip of the returned ar-1995shn had broken off.No fragments were returned for inspection.It was not indicated if a torque-indicating adapter had been used with the device.The cause remains undetermined.A probable cause is attributed to over-torquing/over-engaging the driver within the screw head.

• 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: 15535243
• Report Number: 1220246-2022-05569
• Device Sequence Number: 5415380
• 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): 12/28/2022

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
• Device Lot Number: 10288586
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 12/28/2022
• 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