MAUDE Adverse Event Report: ARTHREX, INC. CLAVICLE IM DEVICE, 2.7MM X 80MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	CLAVICLE IM DEVICE, ¿2.7MM X 80MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2021
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.
Event or Problem Description
It was reported that an implanted 1335-080 clavicle nail broke post-op.The original procedure was done in (b)(6) 2020.The revision procedure is scheduled for (b)(6) 2021 to take place at the same facility as the primary surgery.
Additional Manufacturer Narrative
- it was reported that the device broke post-op.- visual evaluation identified that the implant broke.However, without the return of the product, further investigation cannot be performed.Additionally, patient compliance and bone quality were not reported.- the root cause of the reported failure mode is undetermined.- the reported event is confirmed based on the investigation of the returned x-ray.

• Brand Name: CLAVICLE IM DEVICE, 2.7MM X 80MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11730951
• Report Number: 1220246-2021-02972
• Device Sequence Number: 4253789
• Product Code: HSB
• UDI-Device Identifier: 00848665023763
• UDI-Public: 00848665023763
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K143204
• 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): 09/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CLAVICLE IM DEVICE, ¿2.7MM X 80MM
• Device Catalogue Number: 1335-080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other