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

Model Number	72200419
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a shoulder scope and subscapular repair procedure, the monofilament of the accu-pass advanced out of the tip only about 2 inches before it stopped.Same issue occurred with the second monofilament.The procedure was successfully completed without significant delay using the same device by taking out the second monofilament with a hemostat.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.A visual inspection found the monofilament was passed through the device in a loop.There was no debris or damage.The device was returned without the spare monofilament.A functional evaluation revealed the wheel assembly moves freely with both one finger and two fingers turning the wheels.The monofilament could be advanced further than two inches.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found statements pertaining to the proper advancement of the monofilament.Rolling the wheels forward and backward may initiate tangling or wrapping of the monofilament around the wheels.The roller wheels perform best with continuous movement in the same direction.Please note that the monofilament advances forward using rotation of wheels in a backward direction toward the user.Keeping light tension on the tail of the filament helps the roller feed smoothly.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
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11228904
• Report Number: 1219602-2021-00205
• Device Sequence Number: 3805277
• Product Code: LXH
• UDI-Device Identifier: 03596010542397
• UDI-Public: 03596010542397
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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: 02/05/2023
• Device Model Number: 72200419
• Device Catalogue Number: 72200419
• Device Lot Number: 2049565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/11/2021
• 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: Other; Required Intervention