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	Failure of Implant (1924)
Date of Event	10/14/2022
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 plate has broken medially, through the suture and screw holes.Patient did not fall to cause breakage.Plate was implanted on (b)(6) 2022.Second surgery was done on (b)(6) 2022.No further information received.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-2657dls serial/batch number (b)(6) was received for investigation.No functional testing for this device due to the damage.Visual inspection found that the plate broke in two pieces between holes 16 and 17.Additional observation noted damage on some of the threaded holes.The most likely cause of this can be attributed to use error.Per dfu-0192.Precautions: 3.Do not bend the plate near the locking hole.Bending the plate near the locking hole can distort the hole threading, which prohibits the insertion of the crew.4.Repeated bending of the plate at the same location or by creating excessive acute angles may potentially lead to premature plate fatigue, failure, and or breakage in situ.Use error.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16086407
• Report Number: 1220246-2023-06007
• Device Sequence Number: 16681110
• Product Code: HRS
• UDI-Device Identifier: 00888867027527
• UDI-Public: 00888867027527
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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: DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, SS
• Device Catalogue Number: AR-2657DL
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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