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	Failure to Eject (4010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder procedure, the surgeon tried to pass the monofilament through and it wouldnt progress, he then removed and tried with the back-up that is sent in the pack, again it wouldnt progress.Backup device was available to complete the procedure.No significant delay and no patient injuries 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 reported 45 degree curved right accu-pass suture shuttle, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.However, a trend of this nature has been observed with this product line in the field, prompting a corrective action investigation.As a result of the investigation the following actions were implemented.The bend test was updated, including testing to evaluate the force required to move the monofilament in the accu-pass devices providing a quantitative value in order to remove the human element in the acceptance or rejection of the parts.The ultrasonic welder was re-qualified to include new parameters.A review of the complaint and manufacturing records was performed which confirmed the reported device lot in question was manufactured prior to these changes.

• 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: 10307848
• Report Number: 1219602-2020-01105
• Device Sequence Number: 860583
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 2040027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1