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 Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the accupass mono-filament would not progress through the shaft, making it unable to be used; 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
The device, which was used in a procedure, was not returned for evaluation.A relationship, if any, between the device and the reported incident could not be confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.Factors that are known to contribute to the alleged fault/failure may include mishandling during shipping.If the product is returned in the future the complaint can be reopened and evaluated.

• 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: 10365880
• Report Number: 1219602-2020-01170
• Device Sequence Number: 11628754
• Product Code: LXH
• UDI-Device Identifier: 03596010534453
• UDI-Public: 03596010534453
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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
• Device Lot Number: 2049588
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1