MAUDE Adverse Event Report: ARTHREX, INC. CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, STAINLESS STEEL; WASHER, BOLT, NUT

Catalog Number	AR-2652CR
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device met all material specifications as received.The evaluation revealed the plate broke approximately at the medial section.The fracture face runs diagonally through one of the lateral oblong holes.Features observed on the fracture surface are typically seen on metal fracture due to metal fatigue from bending stress that exceeded the fatigue strength of the material.Device history record review revealed nothing relevant to this event.Based on the event description and observed evidence, the most likely cause for the complainant's event was in-vivo loading of the device possibly causing a fatigue fracture and/or patient non-compliance with the post-op protocol.Per product directions for use (dfu-0192), post-operatively, until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.This is the second complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient underwent a clavicle fracture procedure where a clavicle fracture plate (lot: 5231615, line 197326) was implanted.The patient had reported to surgeon that he was driving, had to hit his brakes, and the plate broke.The plate was removed on (b)(6) 2017 and replaced with another manufacturer's plate.All original screws were also explanted.Screw part and lot numbers were note provided.

• Brand Name: CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, STAINLESS STEEL
• Common Device Name: WASHER, BOLT, NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6692683
• Report Number: 1220246-2017-00243
• Device Sequence Number: 19046407
• Product Code: HTN
• UDI-Device Identifier: 00888867027435
• UDI-Public: 00888867027435
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2017

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 Catalogue Number: AR-2652CR
• Device Lot Number: 5261615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR
• Patient Weight: 91