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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
Lot Number 2394788
Device Problems Break; Material Fragmentation
Event Date 09/11/2018
Event Type  Injury  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Patient code (b)(4) used for: the reamer broke intraoperatively, and fragment remains in the patient. Without a lot number the device history records review could not be completed. Product was not returned. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device was used for treatment, not diagnosis. (b)(4).

 
Event Description

It was reported that on an unknown date, a patient underwent a hardware removal of an unknown broken device. As per surgeon, it was more of a risk to take the broken device out so it was left in the patient. The unknown screw they were in the process of removing was removed successfully. The reamer that broke is a one time use item placed in the broken screw removal set and processed in sterile processing department. The shukla medical screw removal set was the one they originally wanted but had a hole in the blue wrap. Patient and procedure outcome is unknown. This complaint one (1) device. This report is 1 of 1 for (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
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 Key7967463
Report Number2939274-2018-54390
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type OTHER
Type of Report Initial,Followup,Followup
Report Date 09/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device LOT Number2394788
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/27/2008
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: 10/15/2018 Patient Sequence Number: 1
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