MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK); FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72202631
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the device was introduced it broke.No patient injury was reported.
Additional Manufacturer Narrative
One 6.5 twinfix ultra ha anchor assembly was returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.The anchor is cracked in multiple places and is missing a small piece of its threads.Removal of the anchor confirmed the inserter tines are bent and twisted.The condition of the anchor indicates it was subjected to excessive force during insertion.Per the device ifu under precautions ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device¿.Further investigation is not warranted at this time.
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.
Event or Problem Description
It was reported that when the device was introduced it broke inside the patient.All pieces were removed.No patient injuries were reported.

• Brand Name: TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7294303
• Report Number: 1219602-2018-00262
• Device Sequence Number: 1994165
• Product Code: MAI
• UDI-Device Identifier: 03596010647610
• UDI-Public: (01)03596010647610(17)181130(10)50485182
• Combination Product (Y/N): N
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/03/2018

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: 11/30/2018
• Device Model Number: 72202631
• Device Catalogue Number: 72202631
• Device Lot Number: 50485182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 02/23/2018; 04/02/2018; 04/30/2018
• Initial Report FDA Received Date: 02/24/2018
• Supplement Report FDA Received Date: 03/20/2018; 04/10/2018; 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR