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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; WIRE, SURGICAL

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC; WIRE, SURGICAL Back to Search Results
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2018
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown cable/wire/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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
It was reported that during an unknown procedure on (b)(6) 2018, a cable tensioner with pistol grip was used to tension a cable that was in a patient on the proximal femur.Upon tensioning the cable, the tensioner sheared the cable at the rear locking mechanism.This lead to another cable being opened.There was a short surgical delay of five (5) minutes.Fragments generated from broken device was easily removed.Procedure outcome was successfully completed.There was no patient harm due to the reported issue.This report is for one (1) unknown cable/wire.This is report 2 of 2 for complaint (b)(4).
 
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Type of Device
WIRE, SURGICAL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8237876
MDR Text Key132918400
Report Number2939274-2019-55783
Device Sequence Number1
Product Code LRN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/16/2018
Initial Date FDA Received01/10/2019
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 Unknown
Patient Sequence Number1
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