MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP FIXED REF FEM SIZER; KNEE INSTRUMENT : ALIGNMENT DEVICES

Model Number	9505-01-263
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that one of the posterior feet of the fixed reference sizer was found bent.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA HP FIXED REF FEM SIZER
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11738652
• Report Number: 1818910-2021-09060
• Device Sequence Number: 11720619
• Product Code: HWT
• UDI-Device Identifier: 10603295225669
• UDI-Public: 10603295225669
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 9505-01-263
• Device Catalogue Number: 950501263
• Device Lot Number: A0309
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1