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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,RT,SS
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/17/2019
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.
Event or Problem Description
It was reported that a couple of weeks after an initial surgery the clavicle plate broke over the oblong hole.A revision surgery was performed to address the issue.17-feb-2020: further information received that the initial surgery was a clavicle fracture surgery and was performed on (b)(6) 2019 and the revision surgery took place on (b)(6) 2020.The plate was replaced with another manufacturer's fracture plate and the surgery was successful.
Additional Manufacturer Narrative
Complaint confirmed, the plate broke in two near the middle oblong hole.Evaluation shows the plate was bent about 10-20 degrees before breaking.Likely causes include post-op non-compliance, non-union of the bone.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,RT,SS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9750664
• Report Number: 1220246-2020-01703
• Device Sequence Number: 19590428
• Product Code: HRS
• UDI-Device Identifier: 00888867027435
• UDI-Public: 00888867027435
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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
• Device Catalogue Number: AR-2652CR
• Device Lot Number: 5261924
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other