MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 PROXIMA MI CALCAR REAMER SMALL; HIP INSTRUMENTS : REAMERS

Catalog Number 940080007

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2017

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

Thr: alfred roy fremantle hospital (b)(6) 2018.Both of the calcar reamers were reported blunt by the surgeon during the case.There was no adverse event to patient or delay in surgery, as were able to open another tray immediately and use a sharper reamer fit for purpose.Patient id: (b)(6).

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PROXIMA MI CALCAR REAMER SMALL
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS118 DT; UK LS118DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7776752
• MDR Text Key: 116917458
• Report Number: 1818910-2018-66440
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295223627
• UDI-Public: 10603295223627
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

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: 940080007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 11/07/2018
• 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: Initial
• Patient Sequence Number: 1