MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7210424
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a surgery the accu-pass suture shuttle was opened and it had a malfunction, the pre-loaded monofilament was not able to roll in with the help of a sliding wheel, it was tight at one end and at the same time unable to slide in the monofilament.The procedure was completed with a back-up device.It is unknown if there was significant delay.No patient injuries or 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: 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 complaint history review concluded this was a repeat issue.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.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11537182
• Report Number: 1219602-2021-00587
• Device Sequence Number: 4087401
• Product Code: LXH
• UDI-Device Identifier: 03596010534453
• UDI-Public: 03596010534453
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 7210424
• Device Catalogue Number: 7210424
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1