MAUDE Adverse Event Report: INNOMED, INC. PATELLA COVER PLATE SMALL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	4230-01
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 12/05/2024, stryker reported (pr id (b)(6)) to innomed, inc.That stryker catalog #4230-01nm was misplaced during surgery by the surgical team.The surgical team identified the issue via imaging after the procedure.The patient required a second surgery to remove the patella plate.At the time of the report, neither stryker nor the end user had reported the event as mandated by the fda mdr requirements.Innomed, inc.Requested that the device be returned to confirm it to be an innomed device had perform a proper evaluation.After multiple requests by innomed, inc., stryker reported to innomed, inc., that they could not obtain the device or any add'l info from the reporter.Based on the limited info provided, there is no indication that the device failed, and innomed believes the surgical team failed to account for the device before completing the procedure, causing add'l surgery to recover the device.Ref: innomed, inc.Customer feedback (b)(4) for details.

• Brand Name: PATELLA COVER PLATE SMALL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): INNOMED, INC.
• MDR Report Key: 21900699
• Report Number: MW5169492
• Device Sequence Number: 15631408
• Product Code: LXH
• UDI-Device Identifier: 00840277107817
• UDI-Public: 00840277107817
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 4230-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2025
• 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
• Patient Age: 73 YR
• Patient Sex: Female