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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,RT,SS, STRL
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/15/2021
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 a clavicle revision surgery was performed on the (b)(6) 2021 due to a breakage of the device.The initial surgery took place on the (b)(6) 2021 and 7 weeks after the device was implanted it broke with partial loading, without trauma and improper treatment.There was no evidence for an infection.The revision surgery was finished successfully with a new device with the same part number and no broken parts remained inside the patient.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-2652crs, four locking screws, and two non-locking screws were received for investigation.Visual inspection identified that the returned ar-2652crs had broken into two pieces.It was determined that the threaded holes along the plate were stripped/damaged.Surface damage was also present along the plate fragments.The width and thickness of the plate material was assessed using micrometer digital blade id: (b)(4), and the returned device was found to meet design specifications.The cause remains undetermined.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,RT,SS, STRL
• Common Device Name: PLATE, FIXATION, BONE
• 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: 12984818
• Report Number: 1220246-2021-04107
• Device Sequence Number: 17606842
• Product Code: HRS
• UDI-Device Identifier: 00888867195868
• UDI-Public: 00888867195868
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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 Model Number: CLAV FRAC PLT,CENTRAL THIRD,RT,SS, STRL
• Device Catalogue Number: AR-2652CRS
• Device Lot Number: 5261615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown