MAUDE Adverse Event Report: ARTHREX, INC. INTERNALBRACE LIGAMENT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number INTERNALBRACE LIGAMENT

Device Problem Break (1069)

Patient Problem Nerve Damage (1979)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

During a ucl internal brace procedure it was reported the handle on the drill guide snapped off the guide during drilling.This left a plastic tab, which was still spinning and cut a branch of the ulnar nerve.A new kit was then opened and the internal brace procedure was completed with no further issues.Then the doctor stitched the nick to repair the branch of the ulnar nerve.He used a 7-0 size suture for the repair.The case was delayed approximately 20 minutes due to this issue.At this time the there is no clinical patient effect from the procedure.The patient will be observed for the next few weeks to see if any damage to the nerve will be an issue.

• Brand Name: INTERNALBRACE LIGAMENT
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 8155536
• MDR Text Key: 130254237
• Report Number: 1220246-2018-00795
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867096080
• UDI-Public: 00888867096080
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: INTERNALBRACE LIGAMENT
• Device Catalogue Number: AR-1688-CP
• Device Lot Number: F196850
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other