MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MINITAC 2.0 DURABRAID; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72200795
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a collateral ligament repair surgery, the suture of the minitac suture anchor (2.0 ti) broke.The anchor stayed inside the patient.The procedure was successfully completed without significant delay using a back-up device into an additional bone hole.No patient injuries 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 2.0 minitac w/durabraid used in treatment, was returned for evaluation.Instruction for use contains precautionary statements and recommendations for proper use of product.Two short, torn suture segments were returned with the inserter.No anchor was returned.There was no obvious damage or reason for product failure observed.No sharp edges noted.Per ifu: pre-drilling is recommended.Only use the drill provided with the preloaded mini tac 2.0 mm suture anchor.Do not use any other drilling device for the mini tac 2.0 mm suture anchor.Disengage the suture anchor from the inserter: hold the handle securely in the palm and pull back on the finger grips using two fingers to retract the suture tensioning mechanism.While holding the tensioning mechanism in the back position with the finger grips, slowly remove the inserter from the insertion site until the suture tips are visible.The suture will release and feed through the inserter as it is removed.Alternatively: pull back on the finger grips and unwind the suture with the free hand.Slowly remove the inserter.As the inserter is removed, pinch the suture below the inserter using the free hand to verify suture release from the inserter.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.

• Brand Name: MINITAC 2.0 DURABRAID
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9963617
• Report Number: 1219602-2020-00656
• Device Sequence Number: 11461656
• Product Code: MBI
• UDI-Device Identifier: 03596010585998
• UDI-Public: 03596010585998
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 08/27/2023
• Device Model Number: 72200795
• Device Catalogue Number: 72200795
• Device Lot Number: 50755112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 63