MAUDE Adverse Event Report: ANTHREX ARTHREX SWIVELOCK, (3.5 X 15.8)

Catalog Number AR2325BCCC

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Alteration In Body Temperature (2682)

Event Date 05/17/2017

Event Type  Injury  

Event Description

A pt was diagnosed with a left recurrent anterior shoulder instability.On (b)(6) 2017 in surgery during an anterior capsular shift with anterior-inferior labral repair, approx 1/4 of the suture anchor broke off and was removed from the pt successfully and additionally, on 2.9-mm pushlock anchor superiorly at the biceps anchor.

• Brand Name: ARTHREX SWIVELOCK, (3.5 X 15.8)
• Type of Device: SWIVELOCK
• Manufacturer (Section D): ANTHREX; erwin-hielscher-str.; munchen 98124 9; GM 981249
• MDR Report Key: 6633125
• MDR Text Key: 77419471
• Report Number: MW5070290
• Device Sequence Number: 1
• Product Code: MBI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AR2325BCCC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 30 YR
• Patient Weight: 79