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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REAMING ROD PUSH ROD WITH BALL HANDLE REAMER

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC REAMING ROD PUSH ROD WITH BALL HANDLE REAMER Back to Search Results
Model Number 03.010.093
Device Problems Device-Device Incompatibility; Material Twisted / Bent
Event Date 02/24/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the rod pushers do not fit properly through the reaming rod because one is bent and the other is too big. A replacement rod pusher was used to complete the procedure successfully with a surgical delay of five (5) minutes. Concomitant device: unknown reaming rod (part # unknown, lot # unknown, quantity # 1). This report is for one reaming rod push rod with ball handle. This is report 1 of 2 for (b)(4).

 
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Brand NameREAMING ROD PUSH ROD WITH BALL HANDLE
Type of DeviceREAMER
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
SZ  78532
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key9865859
Report Number2939274-2020-01458
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/23/2020
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number03.010.093
Device Catalogue Number03.010.093
Device LOT NumberT958995
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/17/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/04/2011
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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