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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREW, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREW, FIXATION, BONE Back to Search Results
Catalog Number UNK - SCREWS: 4.5/6.5 MM HEADL
Device Problem Appropriate Term/Code Not Available
Event Date 11/21/2019
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown screws: 4. 5 mm and 6. 5 mm headless compression/ 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. Reporter is synthes sales consultant. (b)(4). 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 on (b)(6) 2019, during orthopedic procedure, the unknown screws tray was not properly signed-in with sterile processing department. It was left in the transport tote and placed in the sterile implant room. White glove service was selected and specific delivery instructions were dictated. The tray was not located until the patient was under anesthesia. Due to it not being ready for use, the surgeon was forced to use a competitor's product (not the intended size or material requested for the patient). This event caused surgical interruption, divergence from pre-operative plan, and cost a sale to the competitor. There was a surgical delay of fifteen (15) minutes. Procedure was successfully completed. Patient outcome is unknown. This report is for unknown screws: 4. 5 mm and 6. 5 mm headless compression. This is report 1 of 1 for complaint (b)(4).

 
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Brand NameUNK - SCREWS: 4.5 MM AND 6.5 MM HEADLESS COMPRESSION
Type of DeviceSCREW, FIXATION, BONE
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 Key9447250
Report Number2939274-2019-62626
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK - SCREWS: 4.5/6.5 MM HEADL
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 Received12/06/2019
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: 12/10/2019 Patient Sequence Number: 1
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