MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC*CALIBRATED PAT CUT GDE; PATELLA CUT GUIDE

Catalog Number 865034

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2017

Event Type  malfunction  

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 Description

During the cutting of the patella through the clamp, the guiding guide capture broke off.

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.

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary: examination of the submitted cutting guide confirms the reported event.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PATELLA CUT GUIDE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582
• MDR Report Key: 7116592
• MDR Text Key: 95732591
• Report Number: 1818910-2017-51624
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295216599
• UDI-Public: 10603295216599
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• 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

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 865034
• Device Lot Number: SO2022802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 95