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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW COUPLING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW COUPLING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 03.037.026
Device Problems Break (1069); Entrapment of Device (1212); Device-Device Incompatibility (2919)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/06/2020
Event Type  Injury  
Manufacturer Narrative
Without a lot number the device history records review could not be completed. Product was not returned. 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 on (b)(6) 2020, a helical blade/screw coupling screw had an issue during surgery. During insertion of the lag screw the coupling screw would disengage and unwind, the surgeon repeatedly had to retighten the connection screw in order to advance the lag screw which he had difficulty inserting as the patient had hard/dense bone and the surgeon did not tap for the lag screw. Upon post-op images being taken it was noticed that there were two small metal fragments in the patient soft tissue which appear to be some of the threads from the coupling screw. There was no surgical delay reported. The surgery was completed successfully. The patient outcome was successful. This report is for one (1) helical blade/screw coupling screw. This is report 1 of 2 for (b)(4).
 
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Brand NameHELICAL BLADE/SCREW COUPLING SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10941694
MDR Text Key219493110
Report Number2939274-2020-05431
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.026
Device Catalogue Number03.037.026
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/03/2020 Patient Sequence Number: 1
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