MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNOT MANIPULATOR XL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	72202587
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during procedure, knot pusher was breaking the suture on qfix anchor.The procedure was completed using a back-up device.No patient injury or other complications were reported.There was a delay greater than 30 minutes.
Additional Manufacturer Narrative
One knot manipulator xl was returned for evaluation.The device is over five years old and shows normal wear.Using a stereo microscope the distal end of the manipulator was examined and no sharp edges were observed.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.This investigation could not identify any evidence of product contribution to the reported complaint.

• Brand Name: KNOT MANIPULATOR XL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8746910
• Report Number: 1219602-2019-00757
• Device Sequence Number: 1668807
• Product Code: LXH
• UDI-Device Identifier: 03596010651440
• UDI-Public: 03596010651440
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/22/2019

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 Catalogue Number: 72202587
• Device Lot Number: 50477306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 06/30/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1