MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. US 1818910 P.F.C. T-HANDLE; HIP INSTRUMENTS : IMPACTORS

Catalog Number 853965

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2018

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

It was reported that the surgeon was using the t-handle to ream the femoral canal and the t-handle was not turning the reamers anymore and the t-handle adapter was stripped.

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.

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.

• Brand Name: P.F.C. T-HANDLE
• Type of Device: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. US 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8119559
• MDR Text Key: 128879551
• Report Number: 1818910-2018-76725
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295207801
• UDI-Public: 10603295207801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 853965
• Device Lot Number: AK0601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 01/28/2019; 01/03/2019
• Supplement Dates FDA Received: 01/01/2019; 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2001
• 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