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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/02/2023
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 screw has loosened in the clavicle plate.No further information received.27-jun-2023 update dw: further information were provided that the following devices became loose post op.Ar-2652cl batch: 5262102, ar-8835l-14 batch: 15040867, ar-8835-14 batch: 10694746, 2x ar-8835-16 batch: 1072011, 3x ar-8835-18 batch: 10591283, ar-8827-14 batch: 1074240.As the reported devices are available for return a revision surgery had to be performed but no further information were provided when the revision surgery was performed.13-jul-2023 update dw: further information were provided that a revision surgery was performed with a device from another manufacturer.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-2652cl clavicle fracture plate, central third, left, ss, batch 5262102, was returned for investigation.The returned device was visually inspected, and it was noted that the plate was broken into two pieces at one of the compression slots close to the middle of the plate; besides, a bent was noted in one of the compression slots close to the locking hole.Upon functional testing with the returned low-profile and the low-profile locking screws, it was found that only the low-profile locking screw sits flush and threads entirely.The other returned low-profile screws do not fit the locking or compression holes.The fit is too loose.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause for the reported failure is a user error.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17549799
• Report Number: 1220246-2023-07508
• Device Sequence Number: 17806806
• Product Code: HRS
• UDI-Device Identifier: 00888867027428
• UDI-Public: 00888867027428
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
• Device Catalogue Number: AR-2652CL
• Device Lot Number: 5262102
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2021
• 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