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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*REAMER PROXIML FEM 14B HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS INC US S-ROM*REAMER PROXIML FEM 14B HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 534702
Device Problems Break; Fitting Problem
Event Date 10/02/2019
Event Type  Injury  
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. (b)(4).

 
Event Description

It was reported that the shaft pilot was come off from the cone reamer (p/n: 534702) when the surgeon took the instruments out from medullary cavity during the tha surgery which was combined with osteotomy surgery on (b)(6) 2019 and the shaft pilot was remained in medullary cavity. It was difficult to remove the shaft pilot, and it was removed by performing osteotomy first. The surgeon considered it had not been connected properly and attempted using it again after reattached them however the same issue occurred. The surgery was completed within a 30 minutes surgical delay. Dr¿s view: it was able to remove the shaft pilot after the osteotomy, but it may have been difficult to remove if it occurred during normal surgery. There was a possibility of it was happened because it might be easily detached due to deterioration over time of the joint part. No further information is available.

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary ==> following review of the information received, it was concluded that it was unlikely that a potential product issue was present. The complaint shall be entered onto the complaints database and monitored through trend analysis. Should further information be received, then the complaint shall be reviewed and further investigation completed as required. 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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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
1210 ward av
west chester , PA 19380-0988
6107428552
MDR Report Key9240443
Report Number1818910-2019-112193
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number534702
Device LOT NumberMT43833
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/11/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/14/2016
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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