MAUDE Adverse Event Report: ARTHREX, INC. DRV SFT,T10 HEXALOBE,CANN,STR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number DRV SFT,T10 HEXALOBE,CANN,STR

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

It was reported that during a syndesmoses surgery the tip of driver shaft twisted completely and a small piece broke off.All the fragments were retrieved.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or perform a second surgery.

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.

Manufacturer Narrative

Complaint confirmed.Visual investigation, it was noted that the drive geometry at the distal tip of the returned ar-8737-26 had twisted and broke at the tip.No fragments were returned for inspection.It was not indicated if a torque-indicating adapter had been used with the device.A probable cause is over-torquing/over-engaging the driver within the screw head.The observed condition is attributed to undetermined.

• Brand Name: DRV SFT,T10 HEXALOBE,CANN,STR
• 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: 15615234
• MDR Text Key: 306439930
• Report Number: 1220246-2022-05620
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867046214
• UDI-Public: 00888867046214
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DRV SFT,T10 HEXALOBE,CANN,STR
• Device Catalogue Number: AR-8737-26
• Device Lot Number: 1392129
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/28/2022
• 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