MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T4, NON-RETAINING, MINI AO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T4, NON-RETAINING, MINI AO
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported during a procedure the tip of the ar-18700-29 driver shaft broke off into the screw.The rep reported it was the first screw going in using this screwdriver.The tip broke off flush inside the screw and was left inside the patient.Additional information received on 7/15/2020: the procedure being performed was a pip fracture.The surgeon attempted to remove the broken driver tip from the screw, but decided to leave it as they were worried about trying to hard and losing fixation.The screw was down enough that it could remain implanted and effectively complete the procedure.The remaining portion of the screwdriver is returning for evaluation.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified that the distal, non-retaining tip of the returned ar-18700-29 had broken.The tip chambers were noted to be twisted, and the breakage pattern across the tip indicated that the device broke under torsional strain.Material analysis showed the ar-18700-29 met all as-received specifications.The condition of the returned device is consistent with over-torquing of the driver during use.

• Brand Name: DRIVER SHAFT, T4, NON-RETAINING, MINI AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10337690
• Report Number: 1220246-2020-01991
• Device Sequence Number: 14323738
• Product Code: LXH
• UDI-Device Identifier: 00888867303553
• UDI-Public: 00888867303553
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DRIVER SHAFT, T4, NON-RETAINING, MINI AO
• Device Catalogue Number: AR-18700-29
• Device Lot Number: 1391940
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other