MAUDE Adverse Event Report: ARTHREX, INC. WIRE DRIVER ATTACHMENT 0.6-1.6 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	WIRE DRIVER ATTACHMENT 0.6-1.6 MM
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is not holding the wire.The problem was noticed after the surgery.There was no harm for patient, operator or third party reported.No further information was received.
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.
Additional Manufacturer Narrative
Additional information: h6.The reported event was confirmed.The manufacturer evaluation revealed a worn clamping system resulting in the reported event.Furthermore, the bearing was found worn out as well.The most likely cause is attributed to wear and tear due to repetitive use.

• Brand Name: WIRE DRIVER ATTACHMENT 0.6-1.6 MM
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18073460
• Report Number: 1220246-2023-08567
• Device Sequence Number: 20749507
• Product Code: HWE
• UDI-Device Identifier: 00888867100282
• UDI-Public: 00888867100282
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 01/12/2024

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: WIRE DRIVER ATTACHMENT 0.6-1.6 MM
• Device Catalogue Number: AR-300WD16
• Device Lot Number: 14833444
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown