MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY 7.5 RND RSF PAT TL 29 STD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71932925
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up/ inspection in tka procedure the jrny 7.5 rnd rsf pat tl 29 std was found to be cracked.No delay.There was a s&n back up device available to complete the procedure.No injuries reported at this time.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batch.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY 7.5 RND RSF PAT TL 29 STD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11319808
• Report Number: 1020279-2021-01156
• Device Sequence Number: 17170819
• Product Code: LXH
• UDI-Device Identifier: 00885556059524
• UDI-Public: 885556059524
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 71932925
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1