MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP FEM NOTCH GD SZ 3; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number	9505-01-003
Medical Device Problem Codes	Material Discolored (1170); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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
Instruments show signs of wear and discolourations.Noticed during cleaning process.No surgical affect.No patient affect.Instruments are further in use.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.

• Brand Name: SIGMA HP FEM NOTCH GD SZ 3
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10012588
• Report Number: 1818910-2020-11531
• Device Sequence Number: 19355215
• Product Code: HWA
• UDI-Device Identifier: 10603295224174
• UDI-Public: 10603295224174
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2020

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: 9505-01-003
• Device Catalogue Number: 950501003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 04/24/2020; 05/12/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/01/2020; 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1