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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPARE REAMER TUBE FOR HOLLOW REAMER (309.065)

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPARE REAMER TUBE FOR HOLLOW REAMER (309.065) Back to Search Results
Catalog Number 309.068
Device Problems Break; Material Fragmentation
Event Type  Injury  
Manufacturer Narrative

(b)(6). Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. 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 a patient had a planned competitor¿s hardware (screws) removal. During the procedure, the surgeon removed one screw without difficulty. When he attempted to remove the second screw he was having difficulty. Therefore, the surgeon used the conical extraction screw. During removal, the tip of the extraction screw broke off into the screw the implanted screw head popped off and was retrieved from the patient. The surgeon attempted to use a hollow reamer to remove the screw shaft and the teeth fell off of the hollow reamer into the patient and were not retrieved. It appeared the retained shaft of the screw was fused with the patient¿s bone. The malfunction of the competitor¿s screw led to additional surgical intervention. This was less than a desirable outcome. The patient was stable following surgery. After the procedure, the surgeon told the sales consultant that a 4. 0mm cannulated hexagonal screwdriver got twisted during the surgery. It is unknown how or when the device twisted. The issue of extraction screw has been captured under linked complaint (b)(4). Concomitant devices hollow reamer complete extension (part 309. 065, lot unknown, quantity 1), spare reamer tube (part 309. 480, lot number unknown, quantity 1). This report is for one (1) spare reamer tube for hollow reamer (309. 065). This is report 2 of 2 for complaint (b)(4).

 
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Brand NameSPARE REAMER TUBE FOR HOLLOW REAMER (309.065)
Type of DeviceREAMER
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ  2544
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7268206
Report Number2939274-2018-50619
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number309.068
Device LOT Number213001314
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 Received01/22/2018
Was Device Evaluated By Manufacturer? No Answer Provided
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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