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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.5MM MEDULLARY REAMER HEAD

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.5MM MEDULLARY REAMER HEAD Back to Search Results
Model Number 352.125
Device Problems Device Slipped; Failure to Cut; Device-Device Incompatibility
Event Type  Malfunction  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date, after a visual inspection a synream flexible shaft tip was noticed to be worn and damaged. The synream flexible shaft was tried on different reaming heads and was connected loosely on the shaft. The 12. 5mm synream medullary reamer head fit loosely on the assembly and dull. There was no patient involvement. This report is for one (1) 12. 5mm medullary reamer head this is report 2 of 2 for complaint (b)(4).

 
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Brand Name12.5MM 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
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key8465865
Report Number2939274-2019-57179
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number352.125
Device Catalogue Number352.125
Device LOT Number2100432
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/24/2004
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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