MAUDE Adverse Event Report: ARTHREX, INC. DISTAL CLAVICLE REPAIR ASSEMBLY; WASHER, BOLT NUT

Catalog Number	AR-2658T
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	11/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.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.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Device history record review revealed nothing relevant to this event.Additional information has been requested but not made available.This is the first 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.Device requested but not yet received.
Event or Problem Description
It was reported that the distal clavicle repair assembly, ar-2658t, lot 10031529 ((b)(4)), was being used for a distal clavicle and ac repair procedure on (b)(6) 2016.The ar-2658t includes a preloaded clavicle button for the superior portion of the plate.Also used with the construct was an ar-2270, lot 10039252, dog bone button ((b)(4)) which was attached to the construct and everything was tightened to reduce the separation.The pilot holes for the screws were created by a 3.0 mm cannulated drill.The procedure was completed successfully.A few days after the surgery, the suture pulled out of the tightrope.A revision surgery was performed on (b)(6) 2016 to remove all pieces of the implant assembly.The suture and both buttons were also retrieved from the patient.A third surgery will be necessary to reduce ac after the clavicle is healed.Bone quality: slightly necrotic.

• Brand Name: DISTAL CLAVICLE REPAIR ASSEMBLY
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6132352
• Report Number: 1220246-2016-00533
• Device Sequence Number: 464433
• Product Code: HTN
• UDI-Device Identifier: 00888867183841
• UDI-Public: 00888867183841
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2016

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 Expiration Date: 02/01/2021
• Device Catalogue Number: AR-2658T
• Device Lot Number: 10031529
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 11/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-2270, LOT 10039252, DOG BONE BUTTON
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR