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

Model Number	7210426
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a cuff repair, when passing the suture of the accu-pass, it locked in the wheel.The procedure was successfully completed without a significant delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H10.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.The customer provided image confirmed the product identification information.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: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H6: health code updated.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: part of the reported device was received for evaluation.A visual inspection found no issues.A functional evaluation revealed the devices operated as expected.The wheels moved with ease, without friction.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The customer provided image confirmed the product identification information.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, an impact event inconsistent with normal use, wear from prolonged use, misuse or rough handling, or inadequate routine maintenance.No containment or corrective actions are recommended at this time.

• Brand Name: ACCU-PASS STR SHUTTLE STRAIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11963773
• Report Number: 1219602-2021-01319
• Device Sequence Number: 14200712
• Product Code: LXH
• UDI-Device Identifier: 03596010534477
• UDI-Public: 03596010534477
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/20/2023

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: 02/23/2024
• Device Model Number: 7210426
• Device Catalogue Number: 7210426
• Device Lot Number: 2068824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 08/28/2022; 12/15/2023
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/09/2021; 08/28/2022; 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown