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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 MI CALCAR REAMER SHAFT; HIP INSTRUMENTS : REAMERS
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DEPUY IRELAND 9616671 MI CALCAR REAMER SHAFT; HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 257004500
Device Problems Product Quality Problem (1506); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2018
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
I¿m just with the surgeon at the (b)(6) and he has made a design complaint about the newly launched calcar reamer.This isn¿t specific to this lot number but more a design issue in general.Due to the modular nature of the system,when the handle (d257004500) is screwed onto the end piece (d257004501).The end of the thread protrudes by 1-2mm which means it¿s impossible to get a totally flush cut with the top of the broach.The surgeon feels this has potential for issues with allowing the collar to sit flush with the neck cut for why it¿s designed.This complaint was made today whilst i was in theatre with him.I¿ve attached a picture for your reference.Code: d257004500, lot so2034182 d257004501 lot pg272845, (b)(4).This is a general complaint and doesn¿t involve one particular patient or increased operating time but we would like it registered as a potential design error.
 
Manufacturer Narrative
(b)(4).Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.
 
Manufacturer Narrative
(b)(4).Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.
 
Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  .
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary device history lot : null.Device history batch : null.Device history review : null.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.
 
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Brand Name
MI CALCAR REAMER SHAFT
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key7877612
MDR Text Key120387050
Report Number1818910-2018-69423
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295143192
UDI-Public10603295143192
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number257004500
Device Lot NumberSO2034182
Was Device Available for Evaluation? No
Date Manufacturer Received05/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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