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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8.5MM MEDULLARY REAMER HEAD

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8.5MM MEDULLARY REAMER HEAD Back to Search Results
Catalog Number 352.085
Device Problems Break; Material Fragmentation
Event Date 03/05/2018
Event Type  Malfunction  
Manufacturer Narrative

Patient¿s height is reported as (b)(6). Device is an instrument and is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested and is currently pending completion. 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 during reaming of the medullary canal of the left tibia, the 8. 5mm medullary reamer head broke into several pieces during surgery performed on (b)(6) 2018. All fragments were retrieved from the patient¿s canal. Another reamer head was available to complete the reaming procedure. The im nail was then implanted with no further problem, and no reported patient harm. There was approximately a 20-minute delay to the procedure to retrieve the fragments of the reamer head. This is report 1 of 1 for complaint (b)(4).

 
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Brand Name8.5MM MEDULLARY REAMER HEAD
Type of DeviceREAMER
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ  2545
Manufacturer Contact
michael cote
1302 wright lane east
west chester , PA 19380
6107195000
MDR Report Key7386075
Report Number2939274-2018-51364
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.085
Device LOT Number16715
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 Received05/01/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/02/2007
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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