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

Catalog Number	7210423
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder arthroscopy surgery the frony head of the accu-pass broke off when the suture hook is inserted, all the broken pieces were removed using a grasper.No delay was reported.Surgery was finished with the same device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: one 7210423 accu-pass str shuttle 45 deg lft curve used in treatment was returned for evaluation.Visual assessment confirms the complaint.The information provided states that ¿during a shoulder arthroscopy surgery the frony head of the accu-pass broke off when the suture hook is inserted, all the broken pieces were removed using a grasper¿.Visual assessment showed a cut monofilament.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include improper use of device.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.¿ 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.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ACCU-PASS STR SHUTTLE 45 DEG LFT CURVE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10123574
• Report Number: 1219602-2020-00846
• Device Sequence Number: 2392607
• Product Code: LXH
• UDI-Device Identifier: 03596010534446
• UDI-Public: 3596010534446
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2022
• Device Catalogue Number: 7210423
• Device Lot Number: 2036649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Distributor Facility Aware Date: 05/14/2020
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other