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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT SZ6/7 TAPERED REAMER; HIP INSTRUMENTS : REAMERS
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DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT SZ6/7 TAPERED REAMER; HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 257002300
Device Problems Break (1069); Difficult to Insert (1316); Material Deformation (2976)
Patient Problem Not Applicable (3189)
Event Date 03/27/2018
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Reamer would not fit on t handle connector nor power chuck wear of metal on connecting end due to normal wear.5 minutes delay, time to open other instruments set.No harm to patient.Please replace asap, as instruments set not available for surgeries until replacement comes in bill (b)(6).Item:257002300.Patient consequence? : no.
 
Manufacturer Narrative
(b)(4).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 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.H10 additional narrative: added : h6 product complaint # : (b)(4).Investigation summary
=
> examination of the returned instrument confirmed the complaint.The root cause is attributed to a combination of unintended use error and wear out.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.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.
 
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
SUMMIT SZ6/7 TAPERED REAMER
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7453638
MDR Text Key106257137
Report Number1818910-2018-58078
Device Sequence Number1
Product Code HTO
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,Followup
Report Date 03/28/2018
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 Number257002300
Device Lot NumberJ0108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2019
Initial Date Manufacturer Received 03/28/2018
Initial Date FDA Received04/24/2018
Supplement Dates Manufacturer Received11/09/2018
07/30/2019
07/30/2019
08/30/2019
Supplement Dates FDA Received11/11/2018
08/02/2019
08/29/2019
09/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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