MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T-15, SHORT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER SHAFT, T-15, SHORT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint allegation confirmed.Two unpackaged ar-9545-t15-01 serial/batch number (b)(6) was received for investigation.The visual evaluation found that the driver shaft hexalobe tip was significantly deformed/round.It was noted that the laser etch is wear and tear.The observed event is most likely caused by user mechanical damage to the device, such as prying/leveraging or excessive bending forces applied during use.
Event or Problem Description
On 08/16/2024, it was reported by a sales representative via (b)(4) that (qty.2) of an ar-9545-t15-01 driver shaft and an ar-601-tbc8 ibalance uka, tibial bearing trial was broken (purchased as part of set ar-9501hs univers revers humeral instrument set).There was no case involvement.
Additional Manufacturer Narrative
Corrected information: h1 changed to n/a.Based upon secondary review, it was determined that this event is not a reportable event as there is no case or patient involvement.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon receiving additional information from the field that clarified the event and evaluation of the returned devices, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.

• Brand Name: DRIVER SHAFT, T-15, SHORT
• Common Device Name: ORTHOPEDIC MANUAL SURG 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: jared engle ; 8009337001
• MDR Report Key: 20180011
• Report Number: 1220246-2024-07479
• Device Sequence Number: 8577988
• Product Code: LXH
• UDI-Device Identifier: 00888867225183
• UDI-Public: 00888867225183
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: DRIVER SHAFT, T-15, SHORT
• Device Catalogue Number: AR-9545-T15-01
• Device Lot Number: 8001737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown