MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM, BLUE/WHTE & BLUE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203103
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the twinfix broke when the anchor was turned.No patient injury reported.
Additional Manufacturer Narrative
One 4.5 twinfix ultra pk anchor assembly was returned for evaluation.Visual assessment confirmed the reported breakage.The distal tip of the anchor has broken off at the suture eyelet.The inserter shaft is bent.The inserters¿ tines are bent and twisted.No suture was returned.This condition of the device indicates the anchor was subjected to excessive forces as a result of off axis insertion.

• Brand Name: TWINFIX ULTRA PK 4.5MM, BLUE/WHTE & BLUE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7038187
• Report Number: 1219602-2017-01425
• Device Sequence Number: 944274
• Product Code: MBI
• UDI-Device Identifier: 03596010656155
• UDI-Public: (01)03596010656155(17)220519(10)50665361
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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: 05/19/2022
• Device Model Number: 72203103
• Device Catalogue Number: 72203103
• Device Lot Number: 50665361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR