MAUDE Adverse Event Report: TORNIER, INC. INSTITE FT PEEK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 0846832000333

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

Patient Problem No Information (3190)

Event Date 04/29/2015

Event Type  malfunction  

Event Description

Anchor was being placed into right shoulder by the doctor and the tip of the anchor broke, it was still attached to the anchor, just the tip was broken.The physician removed the entire anchor with the broken tip as witnessed by the fellow and the or technician.Another anchor was utilized to anchor the rotator cuff.
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manufacturer response for tornier anchor, 5.5 mm instite ft peek (per site reporter).
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unknown.

• Brand Name: INSTITE FT PEEK
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): TORNIER, INC.; 10801 nesbitt ave south; bloomington MN 55437
• MDR Report Key: 4794638
• MDR Text Key: 21330151
• Report Number: 4794638
• Device Sequence Number: 1
• Product Code: MAI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 0846832000333
• Device Lot Number: AH19073
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2015
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/26/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1