MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CANAL REAMER 8MM BULLET TIP; HIP INSTRUMENT/TRIAL

Catalog Number 200184080

Device Problem Misconnection (1399)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

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 during routine inspection, it was noticed that there was an issue with coupling.

Manufacturer Narrative

The instrument 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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

• Brand Name: CANAL REAMER 8MM BULLET TIP
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 7033056
• MDR Text Key: 92079449
• Report Number: 1818910-2017-28980
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295080398
• UDI-Public: 10603295080398
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 10/17/2017

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: 200184080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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