MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV ISRT SPACER SZ1-2 21M; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74033617
Medical Device Problem Codes	Crack (1135); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a universal insert spacer sz 1-2 21mm was found to have a crack and missing a piece on the underside.As this was noticed upon inspection, there was not patient involvement.
Additional Manufacturer Narrative
The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned univ isrt spacer sz1-2 21m confirms a piece is broken on one side with cracks on the edges.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNIV ISRT SPACER SZ1-2 21M
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12408397
• Report Number: 1020279-2021-06673
• Device Sequence Number: 3349932
• Product Code: JWH
• UDI-Device Identifier: 03596010671981
• UDI-Public: 03596010671981
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/14/2021

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 Model Number: 74033617
• Device Catalogue Number: 74033617
• Device Lot Number: 13GAP7463
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1