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

Model Number	72200419
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a surgery when the accu-pass package was opened the dial was stuck and was not able to roll the suture out of the device.The procedure was successfully completed without delay using a back-up device.No patient injury or 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
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 revealed that the device was returned with the monofilament loaded.It did not have visible debris and appeared to be in good condition.A functional evaluation concluded that the wheels could successfully advance and retract the monofilament without catching or snagging.A review of the device 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 event.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.

• 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: 11592339
• Report Number: 1219602-2021-00750
• Device Sequence Number: 11789266
• Product Code: LXH
• UDI-Device Identifier: 03596010542397
• UDI-Public: 03596010542397
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2022
• Device Model Number: 72200419
• Device Catalogue Number: 72200419
• Device Lot Number: 2042866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1