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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ENDPIECE WITH DOUBLE JOINT APPARATUS, TRACTION, NON-POWERED

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ENDPIECE WITH DOUBLE JOINT APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number 394.44
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Reporter is a j&j sales representative. 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 the (b)(6) as follows: it was reported that on an unknown date, the end piece with double joint no longer threads properly. There was no known hospital or patient involvement. This complaint involves one (1) device endpiece with double joint. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameENDPIECE WITH DOUBLE JOINT
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14360359
MDR Text Key291973524
Report Number2939274-2022-01713
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number394.44
Device Catalogue Number394.44
Was Device Available for Evaluation? No
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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