MAUDE Adverse Event Report: ARTHREX ACCESSORIES, ARTHROSCOPIC; DISPS KIT TRANS TIB ACL W/O SAWB

Model Number LAR1898S

Device Problems Bent (1059); Break (1069)

Patient Problem Pain (1994)

Event Date 05/02/2017

Event Type  Injury  

Event Description

During his postop recovery period patient c/o pain in right thigh.At postop dr.Visit, it was noted that a large portion of the nitinol guidewire remained in the posterior lateral thigh and likely had broken off during the insertion of the set screw and it got bent and broke.Patient had guidewire fragment surgically removed the next day.

• Brand Name: ACCESSORIES, ARTHROSCOPIC
• Type of Device: DISPS KIT TRANS TIB ACL W/O SAWB
• Manufacturer (Section D): ARTHREX; cincinnati OH 45263
• MDR Report Key: 6650135
• MDR Text Key: 77931083
• Report Number: MW5070477
• Device Sequence Number: 1
• Product Code: NBH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: LAR1898S
• Device Lot Number: 10110087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 93