MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MINITAC 2.0 DURABRAID; STAPLE, FIXATION, BONE

Model Number	72200795
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an achiles tendon repair was performed on (b)(6) 2020; on (b)(6) 2020 it was found that the suture site was broken and infiltrated, as per this issue, on (b)(6) 2020 a debriment suture removal was performed.No delay was reported as this was found after the surgery.Medical intervention was required to removed the broken suture.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 72200795 2.0 minitac w/durabraid used in treatment, was not returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customer¿s complaint cannot be confirmed.The information provided states: ¿it was reported that an achiles tendon repair was performed on (b)(6) 2020; (b)(6) 23rd, 2020 it was found that the suture site was broken and infiltrated, as per this issue, on (b)(6) 2020 a debriment suture removal was performed¿.An exact root cause cannot be determined with confidence.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of the complaint and manufacturing records was performed and indicated similar allegations for the lot number reported.

• Brand Name: MINITAC 2.0 DURABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10151604
• Report Number: 1219602-2020-00912
• Device Sequence Number: 2102028
• Product Code: JDR
• UDI-Device Identifier: 03596010585998
• UDI-Public: 03596010585998
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2023
• Device Model Number: 72200795
• Device Catalogue Number: 72200795
• Device Lot Number: 50746104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 06/14/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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