MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 SP2 AP CHAMF BLK POPUP R.H.SZ5; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	966145
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
After years and years of use, the chamfers have collapsed on this block, so it is impossible to make the cuts.Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.
Additional Manufacturer Narrative
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Investigation summary = > examination of the reported event confirmed the reported damage.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SP2 AP CHAMF BLK POPUP R.H.SZ5
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7332340
• Report Number: 1818910-2018-54922
• Device Sequence Number: 148109
• Product Code: HAW
• UDI-Device Identifier: 10603295247005
• UDI-Public: 10603295247005
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K043223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2018

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 Catalogue Number: 966145
• Device Lot Number: GM1204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 04/20/2018; 04/26/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 04/23/2018; 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 86