MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCU-PASS SUTURE SHUTTLE 70 DEGREE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 72200419

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during surgery, the "accupass suture shuttle 70°" did not pass the suture properly.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.

Manufacturer Narrative

H3, h6: 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 a repeat issue.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Internal complaint reference: case-(b)(4).

Manufacturer Narrative

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.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 a repeat issue.A visual inspection revealed the device was returned outside of original packaging.The monofilament was received halfway inside of the handheld instrument.No damage visible.A functional evaluation revealed the device passes suture as intended.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.No containment or corrective actions are recommended at this time.

• Brand Name: ACCU-PASS SUTURE SHUTTLE 70 DEGREE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11823043
• MDR Text Key: 251136278
• Report Number: 1219602-2021-01118
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010542397
• UDI-Public: 03596010542397
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: 72200419
• Device Catalogue Number: 72200419
• Device Lot Number: 2059702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 06/14/2021; 08/18/2021
• Supplement Dates FDA Received: 06/15/2021; 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1