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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an acl procedure, at the moment of passing the suture through the accu-pass through the labrum, after the anchor was placed, the device broke in the part where the curve begins to the right.Part was successfully removed from the patient.Backup device was available to complete the procedure.No significant delay and no patient complications were reported.
Additional Manufacturer Narrative
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.There was a relationship found between the subject device and the reported incident.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 an isolated event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A review of the customer provided image reveals a monofilament is in the device and the distal tip of the needle has become separated from the shaft.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.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: 11808974
• Report Number: 1219602-2021-01093
• Device Sequence Number: 3909917
• Product Code: LXH
• UDI-Device Identifier: 03596010534453
• UDI-Public: 03596010534453
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 06/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2023
• Device Model Number: 7210424
• Device Catalogue Number: 7210424
• Device Lot Number: 2057177
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: Required Intervention