MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TIBIAL SPACER BLOCK WIDE; PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL

Model Number	74012646
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument developed a chip.This was found during set up / inspection.No surgery or patient involvement.
Additional Manufacturer Narrative
Results of investigation: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is damaged with a chip, rendering the device inoperable.The device was manufactured in 2012 and shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.

• Brand Name: TIBIAL SPACER BLOCK WIDE
• Common Device Name: PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10587478
• Report Number: 1020279-2020-04863
• Device Sequence Number: 19590061
• Product Code: JWH
• UDI-Device Identifier: 00885556003398
• UDI-Public: 00885556003398
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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 Model Number: 74012646
• Device Catalogue Number: 74012646
• Device Lot Number: 12DM02304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1