MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	7210708
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ligament repair in proximal humerus, the device was stripped.Bone was already pre-drilled, but the device was still stripped.The device broke inside the patient and broken pieces were removed with tweezers and pliers.The back up device was used in an additional bone hole and the procedure was completed with no delay or patient injury reported.
Additional Manufacturer Narrative
Please be advised that two devices were received from two different lot numbers and customer confirmed that both devices had the same issue; therefore, while mdr 1219602-2019-00967 covers lot number 2025180, mdr 1219602-2019-01180 covers lot number 50779386.Two 5.0mm twinfix ti w/needle assemblys were returned for evaluation.Visual assessment of lot 2025180 confirmed the reported complaint.The anchor hex/eyelet is stripped and has damage from what appears to some type of grasping device.The shaft is dramatically bent and twisted.Visual assessment of lot 50779386 confirmed the shaft is dramatically bent and twisted.Only the inserter was returned for examination no anchor, suture, needles or the removable section of the handle.The condition of the devices indicates they were subjected to excessive force during use.Per the device instructions for use: ¿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¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TWNFX TI 5.0 STR ANCHR W/2 ULTRB STR N
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9128193
• Report Number: 1219602-2019-01180
• Device Sequence Number: 3221568
• Product Code: MBI
• UDI-Device Identifier: 03596010532206
• UDI-Public: 03596010532206
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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: 01/03/2024
• Device Catalogue Number: 7210708
• Device Lot Number: 50779386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1