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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT REAMER

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT REAMER Back to Search Results
Catalog Number 352.040
Device Problem Device-Device Incompatibility
Event Date 06/04/2019
Event Type  Injury  
Manufacturer Narrative

Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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

It was reported that on (b)(6) 2019, a medullary reamer head was disengaged from the reamer shaft during a total hip procedure. The surgeon did not place the flexible reamer shaft with reamer head over a reaming rod and the reamer head that was used disengaged from the flexible reamer shaft and was lodged in the femoral canal. They were unable to retrieve the reamer head. Procedure was successfully completed, total hip procedure performed as planned. It was relayed that the patient is recovering fine from the total hip procedure and not given amount of time delayed. There was an attempt to retrieve the reamer head, but that specific information was not supplied, nor was other intervention information. The reason for the total hip procedure was not supplied to sales consultant but mostly performed for osteoarthritis. Sc confirmed this was not a fracture related procedure. Concomitant device reported: unknown flexible reamer shaft (part# unknown, lot# unknown, quantity# 1). This report is for one (1) synream flexshaft. This is report 2 of 2 for (b)(4).

 
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Brand Name5.0MM FLEXIBLE SHAFT
Type of DeviceREAMER
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 80132
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ  2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key8842023
Report Number1719045-2019-50006
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 07/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.040
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 Received08/29/2019
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

Patient TREATMENT DATA
Date Received: 07/30/2019 Patient Sequence Number: 1
Treatment
5.0MM FLEXIBLE SHAFT
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