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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK REAMER

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK REAMER Back to Search Results
Model Number 351.16J
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Malfunction  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is a synthes employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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

It was reported that during a routine inspection on (b)(6) 2020, several issues were noted. The multi hole wire guide tip has been damaged; guide wires cannot go through. The ratcheting screwdriver handle is chipped. The flexible shaft connector for use with jacobs chuck is missing the internal part that locks in shaft. And the handle with quick coupling is broken at the top of the handle. There was no patient involvement. This report is for a flexible shaft connector for use with jacobs chuck. This is report 3 of 4 for (b)(4).

 
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Brand NameFLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11155051
MDR Text Key226577651
Report Number2939274-2021-00188
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/12/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number351.16J
Device Catalogue Number351.16J
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/04/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/14/2017
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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