MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP DIS FEM RESECT GUIDE; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number	9505-01-235
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2020
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
The tool was not performing its functional tasks.The product broke before use due to wear of the product.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: b5, d4 (lot), h4 corrected: b3, h6 (medical device problem code).
Event or Problem Description
Additional information received indicated that the bearing was broken into more than 2 elements.

• Brand Name: SIGMA HP DIS FEM RESECT GUIDE
• 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: 11254619
• Report Number: 1818910-2021-02155
• Device Sequence Number: 14348287
• Product Code: HWT
• UDI-Device Identifier: 10603295225409
• UDI-Public: 10603295225409
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: 9505-01-235
• Device Catalogue Number: 950501235
• Device Lot Number: SO2008113
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1