MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS, STRL; PLATE, FIXATION, BONE

Model Number	CLAV FRAC PLT,CENTRAL THIRD,LFT,SS, STRL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
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 device was implanted on 11-may and during a post-operative check-up an x-ray revealed, that the device was already bend a few days after the surgery.On 16-jun the device broke when the patient was tying his shoes.A revision surgery was performed and the broken device was removed and replaced with a different device.In the meantime, the healing of the fracture already progressed and no further complications occurred.
Additional Manufacturer Narrative
Complaint confirmed, the plate broke at the 2nd oblong hole.The plate is bent near the fracture.Relevant features and the device material were found to meet drawing specifications.The cause of the event remains undetermined.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS, STRL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12163145
• Report Number: 1220246-2021-03373
• Device Sequence Number: 11712628
• Product Code: HRS
• UDI-Device Identifier: 00888867195912
• UDI-Public: 00888867195912
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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 Expiration Date: 01/31/2024
• Device Model Number: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS, STRL
• Device Catalogue Number: AR-2652CLS
• Device Lot Number: 10278376
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other