MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/3UB-WHT,BL &BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202600
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign postal code (b)(6).
Event or Problem Description
It was reported that during application, the device broke.The damaged device was removed from the patient and replaced with a new one in the same bone hole.No significant delay or patient injury was reported.
Additional Manufacturer Narrative
One 5.5 twinfix ultra pk anchor assembly was returned for evaluation.Visual assessment confirmed the reported breakage.The anchor is cracked above the suture eyelet on one side.Dimensional assessment of the anchor confirmed it met print specifications.The condition of the anchor indicates it was subjected to excessive force in conjunction with off axis insertion.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/3UB-WHT,BL &BLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8058438
• Report Number: 1219602-2018-01516
• Device Sequence Number: 2463926
• Product Code: MBI
• UDI-Device Identifier: 03596010647481
• UDI-Public: 03596010647481
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2022
• Device Catalogue Number: 72202600
• Device Lot Number: 2008051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 11/11/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR