MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 ANTEVERSION OSTEOTOME SM; HIP INSTRUMENTS : CUTTING INSTRUMENTS

Catalog Number 200231000

Device Problems Bent (1059); Scratched Material (3020); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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.

Event Description

Mdr let us know that the osteotome was worn and the broach handle was loose.They asked us to replace both.No charge po to follow.Lot #s wouldn't transfer down, nor would the form allow me to enter so they are cv0609 for the osteotome and so2003461 for the broach handle.Entered in serial number.Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.On 5/31/2018: examination of the returned instrument found the cutting edge nicked with material missing.Visual analysis found the remaining portion of the instrument exhibited impaction marks and scratches and also appears to be bent. .

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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: ANTEVERSION OSTEOTOME SM
• Type of Device: HIP INSTRUMENTS : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7650024
• MDR Text Key: 112849758
• Report Number: 1818910-2018-63474
• Device Sequence Number: 1
• Product Code: HWM
• UDI-Device Identifier: 10603295080794
• UDI-Public: 10603295080794
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200231000
• Device Lot Number: CV0609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2009
• 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