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

Catalog Number	966145
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
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.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.
Event or Problem Description
The cutting block is deformed and the cut can be bad.Patient consequence? :no.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: SP2 AP CHAMF BLK POPUP R.H.SZ5
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8146166
• Report Number: 1818910-2018-77615
• Device Sequence Number: 13828384
• Product Code: HAW
• UDI-Device Identifier: 10603295247005
• UDI-Public: 10603295247005
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K043223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: J0600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1