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

Model Number	72202600
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implantation of the anchor, the twinfix ultra broke.No patient injuries were reported.
Additional Manufacturer Narrative
Due to no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.No further actions pursued at this time.

• 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: 7167720
• Report Number: 1219602-2018-00032
• Device Sequence Number: 11209123
• Product Code: MBI
• UDI-Device Identifier: 03596010647481
• UDI-Public: (01)03596010647481(17)220214(10)50647005
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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: 02/14/2022
• Device Model Number: 72202600
• Device Catalogue Number: 72202600
• Device Lot Number: 50647005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1