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

Model Number	72200795
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during a repair of ankle ligament, the minitac suture broke after the anchor was implanted.The broken pieces were retrieved from patient and the procedure was successfully completed without a significant delay using a back-up device.No 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
Internal complaint reference: (b)(4).H10, h3, h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.An analysis of the customer provided image confirmed the part and batch numbers and indicated that the anchor had not been deployed.A visual inspection revealed that the device was returned with the sutures detached.The anchor was still at the distal tip of the device.The sutures appeared to have been cut.There was significant debris on the insertor and anchor.A functional evaluation could not be performed.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.Do not use sharp instruments to manage or control the suture.The instructions also contain steps for if the circumstances necessitate reassembling the suture and anchor to the insertion device, such as surgeon preference for alternate suture with the anchor, or partial deployment of the anchor prior to insertion.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

• Brand Name: MINITAC 2.0 DURABRAID
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11256336
• Report Number: 1219602-2021-00224
• Device Sequence Number: 3649025
• 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): 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2023
• Device Model Number: 72200795
• Device Catalogue Number: 72200795
• Device Lot Number: 50774587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 01/30/2021
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention