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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE, FIXATION, BONE Back to Search Results
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2018
Event Type  Malfunction  
Manufacturer Narrative

Patient¿s weight is unknown. This report is for an unknown plate. Part and lot number are unknown; udi number is unknown. Surgeon implanted the same plate; as such explant date is not applicable. 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. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 two (2) locking screws would not lock into an unknown plate during a hand fracture repair procedure on (b)(6) 2018. The surgeon was manually placing screws through the screw hole of the plate when the two screws malfunctioned. The procedure was completed without incident using two cortex screws. No patient harm was reported. There was a 45 second surgical delay related to switching the screws. The patient outcome was reported stable. Procedure was completed successfully. This report is for one (1) unknown plate. This is report 3 of 3 for complaint (b)(4).

 
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Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7421350
MDR Text Key105533649
Report Number2939274-2018-51579
Device Sequence Number1
Product Code HRS
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
Type of Report Initial
Report Date 03/16/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/11/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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