MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 5.5MM W/3UB-WHT BL &BLK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202600
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during surgery, the tip of the anchor broke while being inserted.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: one 72202600 twinfix ultra pk 5.5mm device used for treatment, was returned for evaluation.Instructions for use contain recommendations and precautionary statements for proper use of product.The inserter was returned with handle and spring action functional.Forks were intact but were bent and flared.Sutures and partial anchor were returned.The anchor was attached to the inserter.Distal threads were missing and not returned with the inserter.Remaining threads were ragged at the distal tip.Product indicated symptoms of excess torque and twisting applied while the anchor was stationary.Inadequate tunnel size would also encourage the symptoms found.Specific prep and use techniques are outlined per instructions for use: if more torque is required to insert the anchor, stop and ensure that the hole size and depth are correct for the bone conditions encountered.It may be necessary to reduce the anchor size or increase the hole size to achieve optimal insertion force.It is the responsibility of the surgeon to determine the patient¿s bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.Breakage of the suture anchor can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.Instructions for use recommends a 4.5 mm spade tip drill for a pilot hole and also a 5.5/6.5 threaded dilator for prep.Complaint history review indicated no similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.No root cause related to the manufacturing of this device was confirmed.
Additional Manufacturer Narrative
H3,h6: one 72202600 twinfix ultra pk 5.5mm suture anchor was used for treatment but not returned for evaluation.Due to unavailability, investigation, evaluation and conclusions were limited.If objective evidence becomes available to assist with evaluation, the complaint may be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 1) alternate prep method, instruments or method used.2) incompatible or unexpected bone density/condition.3) incomplete anchor insertion.4) unexpected bone condition/density.5) use of excess torque.6) loss of or lack of axial alignment.Instructions for use are quite specific for this device.Per ifu 10600571: ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.If more torque is required to insert the anchor, stop and ensure that the drill bit size and depth are correct.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: TWINFIX ULTRA PK 5.5MM W/3UB-WHT BL &BLK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9809067
• Report Number: 1219602-2020-00486
• Device Sequence Number: 19027087
• Product Code: MBI
• UDI-Device Identifier: 03596010647481
• UDI-Public: 03596010647481
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093228
• 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,Followup
• Report Date (Section B): 07/06/2020

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: 12/01/2022
• Device Model Number: 72202600
• Device Catalogue Number: 72202600
• Device Lot Number: 50700316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 04/16/2020; 07/02/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/19/2020; 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1