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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 Operates Differently Than Expected
Event Date 10/25/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation. Concomitant medical products: unknown synthes reamer head, (b)(6) 2017. Without a lot number the device history records review could not be completed. The manufacture date is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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) 2017, a revision surgery involving hardware removal was performed to treat nonunion of a humeral shaft fracture. The original procedure was performed on an unknown date during which the patient was implanted with synthes devices. Subsequently it was determined that there was nonunion. During the revision procedure, as a flexible reamer was being used to widen the canal, the flexible reamer shaft would not hold on to various reamer head sizes. The reamer heads would just slide off and would not catch on to the shaft. The reamer shaft appeared to be worn. Another reamer shaft was available for use. There was no malfunction associated with reamer heads. There was no reported surgical delay. Removed hardware included: one (1) six-hole broad plate and six (6) 5. 0 mm locking screws. All explanted devices were found to be intact. The patient was revised to a new 8-hole broad plate, screws and a fibular allograft. Nothing untoward occurred during this procedure. The procedure was completed successfully with the patient in stable condition. Concomitant devices reported: unknown synthes reamer head. This is report 1 of 1 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 19380
Manufacturer (Section G)
BETTLACH
muracherstrasse 3
bettlach 2544
SZ  2544
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7042641
Report Number2939274-2017-50011
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/17/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.040
Device LOT Number2089471
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/11/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/25/2004
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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