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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM REAMER BLUNT 10.5MM STR HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS INC US SROM REAMER BLUNT 10.5MM STR HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 536850
Device Problem Scratched Material
Event Date 05/28/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Investigation summary: examination of the returned instrument confirmed the complaint. The root cause is attributed to user error. 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. Territory (b)(6) reports that multiple srom reamers were damaged during a surgery with surgeon. The reamers were used to "ream" through some hardware left in a hip. Since the reamers were used to do this, many of them have been damaged and need to be replaced. No further information is available at this time. Examination of the returned reamer confirmed the complaint; the flutes on the reamer are nicked with some areas missing material. The root cause is attributed to use error. Provided information states the reamers were used to "ream" through some hardware left in a hip. Since the reamers were used to do this, many of them have been damaged and need to be replaced. Reamers are not intended to ream through metal hardware, it's intended purpose is to ream bone. The complaint sample consisted of (1) 536850 srom reamer blunt 10. 5mm straight, date code a0800. The date code indicates the instrument was manufactured in august of 2000. Visual analysis found an etching of 2/17 indicating this instrument was reworked for an unknown reason in february of 2017. 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. 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 multiple srom reamers were damaged during a surgery with surgeon. The reamers were used to "ream" through some hardware left in a hip. Since the reamers were used to do this, many of them have been damaged and need to be replaced. No further information is available at this time. No surgical delay.

 
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Brand NameSROM REAMER BLUNT 10.5MM STR
Type of DeviceHIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key8831114
Report Number1818910-2019-99328
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number536850
Device LOT NumberA0800
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/20/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2000
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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