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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 Problem Device-Device Incompatibility
Event Type  Malfunction  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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 synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during an inspection, it was discovered that the shaft part of the reaming rod-push rod is too big and unable to penetrate the synream reaming shaft because of wrong size. There was no patient consequence. Concomitant device reported: flexible shaft (part# 352. 040, lot# unknown, quantity # 1). This complaint involves one (2) device. This is report 2 of 2 for (b)(4).

 
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Brand Name. REAMING 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
GM  78532
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key9953969
Report Number2939274-2020-01809
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number03.010.093
Device Catalogue Number03.010.093
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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