MAUDE Adverse Event Report: ARTHREX, INC. DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, SS; PLATE, FIXATION, BONE

Model Number	DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, SS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2020
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 the clavicula plate broke 8 weeks post op.According to the surgeon, patient was actively working in the garden.Revision surgery was performed on (b)(6) 2020, during the revision, the fracture zone was refreshed and filled up with iliac crest spongiosa and fixated with an arthrex 10 hole plate.
Additional Manufacturer Narrative
Complaint confirmed, the plate was received broken in two.The breakage occurred at a 45° angle across the 4th screw slot.The plate was found to meet dimensional and material specifications.A likely cause of the event is non-union of the bones.

• Brand Name: DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, SS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10962234
• Report Number: 1220246-2020-02393
• Device Sequence Number: 4295990
• Product Code: HRS
• UDI-Device Identifier: 00888867027527
• UDI-Public: 00888867027527
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, SS
• Device Catalogue Number: AR-2657DL
• Device Lot Number: 6791443
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 02/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other