MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MENISCAL STITCHER STR REPL (PKG 1); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	72202868
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stitcher needle broke.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Additional information was received that identified that this event should be re-evaluated for mdr reporting.The additional information received clarifies that the device broke outside the patient.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
Event or Problem Description
It was reported that the sticher needle broke outside the patient.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.

• Brand Name: MENISCAL STITCHER STR REPL (PKG 1)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8503545
• Report Number: 1219602-2019-00417
• Device Sequence Number: 2689950
• Product Code: LXH
• UDI-Device Identifier: 00885554000245
• UDI-Public: 00885554000245
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K834370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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: 72202868
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1