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

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 306625381
• Report Number: 1220246-2022-05569
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867025684
• UDI-Public: 00888867025684
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1