MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 6.5MM W/3 UB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202900
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during surgery, while inserting the anchor into the bone, the device's insertion shaft broke.Since the original anchor could not be screwed in completely, it was extracted.A back-up device was used.No significant delay or patient injury was reported.
Additional Manufacturer Narrative
One 6.5 twinfix ultra ti anchor assembly was returned for evaluation.Visual assessment of the device confirmed the reported breakage.The inserter tip has broken at the weldment.Examination of the weld characteristics confirmed adequate weld penetration between the welded components.The suture and anchor remains attached to the inserter.The anchor is damaged by what looks like some type of grasping device.As reported the insertion site was not pre-drilled.Per the devices under caution: excessive force during insertion can cause failure of the suture anchor or insertion device.A two-finger ao technique should be used to insert the anchor.If more torque is required to insert the anchor, stop and ensure that the anchor size, drill hole size, and depth are correct for the bone conditions encountered.It may be necessary to reduce the anchor size or increase the drill hole size to achieve optimal insertion force".There were no indications that would suggest that the devices did not meet product specifications upon release into distribution.

• Brand Name: TWINFIX ULTRA 6.5MM W/3 UB
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8952636
• Report Number: 1219602-2019-01044
• Device Sequence Number: 11427353
• Product Code: MBI
• UDI-Device Identifier: 03596010652324
• UDI-Public: 03596010652324
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K100159
• 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): 10/18/2019

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: 03/02/2024
• Device Catalogue Number: 72202900
• Device Lot Number: 2029247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1