MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS; WASHER, BOLT, NUT

Model Number	CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/18/2023
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the following devices were implanted on the (b)(6) 2022: ar-2651cl (lot: 5262203); ar-8835-16 (ilot: 14999011); ar-8835l-16 (lot: 14975878) and ar-8835l-18 (lot: 14946776).The plate broke post-op without external influence.On the (b)(6) 2023, it was removed and replaced with a new clavicle fracture plate (ar-2652cl).No further information received.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual inspection, it was noted that the ar-2651cl plate was broken within the 5th screw slot between the ce mark and the batch number; it was also bent on the 7th slot and the left mark.The width and thickness of the plate were measured and found to be within tolerance.The photos provided confirm the plate broke post-operation.The cause of this remains undetermined.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Common Device Name: WASHER, BOLT, NUT
• 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: 16904801
• Report Number: 1220246-2023-06690
• Device Sequence Number: 17847331
• Product Code: HRS
• UDI-Device Identifier: 00888867027404
• UDI-Public: 00888867027404
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Device Catalogue Number: AR-2651CL
• Device Lot Number: 5262203
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown