MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX CRVD AHR S 1 #2 UB STR BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72204687

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/21/2020

Event Type  malfunction  

Event Description

It was reported that during arthroscopy the end of suturefix curved anchor inserter snapped off inside the drill guide.There was a delay of under 30 min and the procedure was completed using the same device.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that during arthroscopy the end of suturefix curved anchor inserter snapped off inside the drill guide.All pieces were removed from the patient.There was a delay of under 30 min and the procedure was completed using the same device.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history 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 issue.A review of the instructions for use found that excessive force can result in device failure.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.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.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: SUTUREFIX CRVD AHR S 1 #2 UB STR BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10668455
• MDR Text Key: 211021894
• Report Number: 1219602-2020-01569
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556686287
• UDI-Public: 00885556686287
• Combination Product (y/n): N
• PMA/PMN Number: K163034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2021

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
• Device Operator: Health Professional
• Device Model Number: 72204687
• Device Catalogue Number: 72204687
• Device Lot Number: 2045906
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 10/09/2020; 03/23/2021
• Supplement Dates FDA Received: 10/21/2020; 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention