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

Model Number 9400-80-007

Device Problems Dull, Blunt (2407); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> examination of the returned instrument found the planer is dull.The root cause is attributed to heavy usage/ wear out.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.Investigation summary: examination of the returned instrument found the planer is dull.The root cause is attributed to heavy usage/ wear out.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.

Event Description

It was reported that calcar planers need to be replaced.No surgical delay.

• Brand Name: PROXIMA MI CALCAR REAMER SMALL
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9510404
• MDR Text Key: 184388863
• Report Number: 1818910-2019-124525
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295223627
• UDI-Public: 10603295223627
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9400-80-007
• Device Catalogue Number: 940080007
• Device Lot Number: ABC14825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2014
• 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