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	12/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during procedure, when the package was opened, the accu-pass could not roll the monofilament out of device.The procedure was completed with the same device with no patient injury or delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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 two nylon monofilaments were returned with the device.The needle did not appear to be deformed.The monofilament was not in device and doesn't appear to be used.No debris on device or sutures.Both sutures appeared to be cut to manufacturer intent.A functional evaluation revealed the suture shuttle moves freely with ease.An attempt to push each suture through the shuttle was successful.No binding of any kind.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 a repeat issue.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.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: 11170189
• Report Number: 1219602-2021-00122
• Device Sequence Number: 11653408
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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 Model Number: 72200419
• Device Catalogue Number: 72200419
• Device Lot Number: 2048121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1