MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAY/ARTICULAR SURFACE INSERTER BOTTOM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	00584305200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tray/articular surface inserter bottom broke during a tka procedure and inside the patient.No surgical delays reported.No information about how the procedure was finished was provided.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the complaint was deemed to be a duplicate of a previously reported event, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: TRAY/ARTICULAR SURFACE INSERTER BOTTOM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10815774
• Report Number: 1020279-2020-06338
• Device Sequence Number: 1872276
• Product Code: LXH
• UDI-Device Identifier: 00885556621653
• UDI-Public: 00885556621653
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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 Model Number: 00584305200
• Device Catalogue Number: 00584305200
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 06/17/2021
• 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