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

Model Number	72202896
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during the rcr procedure, the anchor of the device broke off inside the patient at sulcus.The doctor had to convert to be able to take the anchor out.The anchor did not go all the way down.There was a significant delay of more than 30 minutes and the procedure was successfully completed with a backup device.No patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Two 5.5mm twinfix ultra ti anchor assemblies, intended for use in treatment, were returned for evaluation.The devices were returned in the same shelf carton prohibiting lot verification, as a result the investigation will be added to complaints (b)(4).Visual assessment of each device confirmed the reported complaint of breakage.The distal tip of each inserter shaft has broken off at the weldment.Both anchors were returned and show significant damage to their threads.The break area of the shaft is splayed.Examination of the weldment showed adequate weld on each mating component.As reported the patient had hard bone and no prep devices were used to prepare the insertion site.The condition of the devices indicate they were subjected to excessive force during anchor insertion resulting in the reported breakage.Per the device ifu under precautions: use of 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.The ifu also instruct the end user to drill in hard bone applications.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: TWINFIX ULTRA 5.5MM W/2 UB (BLK & BLUE)
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9511917
• Report Number: 1219602-2019-01594
• Device Sequence Number: 411366
• Product Code: MBI
• UDI-Device Identifier: 03596010652270
• UDI-Public: 03596010652270
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 04/02/2023
• Device Model Number: 72202896
• Device Catalogue Number: 72202896
• Device Lot Number: 2012715
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1