MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2 AP CHAMF BLK POPUP R.H.SZ4; KNEE INSTRUMENT

Catalog Number 966144

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  malfunction  

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 Description

It was reported that the 4 in 1 popup block was broken during surgery.It also states that the top saw capture was broken off.No surgical delay.All pieces retrieved.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: functional testing of the returned device confirmed the reported event.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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint: (b)(4): investigation summary: examination and functional testing of the returned device confirmed the reported event.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: SP2 AP CHAMF BLK POPUP R.H.SZ4
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7122435
• MDR Text Key: 95058882
• Report Number: 1818910-2017-51794
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 10603295246992
• UDI-Public: 10603295246992
• Combination Product (y/n): N
• PMA/PMN Number: K043223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 966144
• Device Lot Number: GM0405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 06/14/2018; 07/20/2018
• Supplement Dates FDA Received: 06/18/2018; 07/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1