MAUDE Adverse Event Report: ARTHREX; DISPOSABLES KIT, TRANSTIBIAL ACL WITH SAW BLADE

Catalog Number AR-1897S

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/16/2017

Event Type  malfunction  

Event Description

The 2cm of the guide wire tip broke off in the 7mm cannulated silk screw.Surgeon made decision to leave broken tip in patient.

• Type of Device: DISPOSABLES KIT, TRANSTIBIAL ACL WITH SAW BLADE
• Manufacturer (Section D): ARTHREX; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 6893209
• MDR Text Key: 87350348
• Report Number: 6893209
• Device Sequence Number: 0
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: AR-1897S
• Device Lot Number: 10072041
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 81