MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202626
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor broke despite using tap.The anchor was completely removed from patient and an additional hole was not needed to finish the procedure.A backup device was available to complete the procedure with no significant delay or patient injuries.Patient injuries reported.
Additional Manufacturer Narrative
One 5.5 twinfix ultra ha inserter was returned for evaluation.Anchor and suture were not returned for examination.Visual assessment of the inserter tines that interface with the anchor are bent and twisted.The condition of the inserter indicates excessive force was placed on the device during insertion of the anchor.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7879097
• Report Number: 1219602-2018-01253
• Device Sequence Number: 1837270
• Product Code: MBI
• UDI-Device Identifier: 03596010647580
• UDI-Public: (01)03596010647580(17)221221(10)50703855
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2018

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: 12/21/2022
• Device Model Number: 72202626
• Device Catalogue Number: 72202626
• Device Lot Number: 50703855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/09/2018; 11/16/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/10/2018; 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1