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

Model Number 72200795

Device Problem Material Separation (1562)

Patient Problem Injury (2348)

Event Date 04/23/2020

Event Type  Injury  

Event 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.

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
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10151604
• MDR Text Key: 195081975
• Report Number: 1219602-2020-00912
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010585998
• UDI-Public: 03596010585998
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention