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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC WASHER 7.0MM; WASHER, BOLT NUT
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC WASHER 7.0MM; WASHER, BOLT NUT Back to Search Results
Model Number 219.98
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.(b)(4).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 or Problem Description
It was reported that on an unknown date, the patient underwent a hardware removal of an anteriormedial distal tibia plate and screws due to infection and non-union.The surgeon removed an anteriormedial distal tibia plate and screws along with some cannulated screws from the distal tibia.The reason for removal is an infected non union.There were no allegations against the devices.The surgeon decided not to take all the hardware out that day and bring the patient back at a later date to remove the rest of it.A distal tibia plate and screw remained in the patient.It was ultimately decided not to remove any more of the hardware because the infection was subsiding.The surgeon put a circular fixator on the ankle for definitive fixation.This product was implanted in (b)(6) 2020.This report is for (1) washer 7.0mm.This is report 12 of 17 for (b)(4).
 
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Brand Name
WASHER 7.0MM
Common Device Name
WASHER, BOLT NUT
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key12453627
Report Number2939274-2021-05301
Device Sequence Number17415199
Product Code HTN
UDI-Device Identifier10886982156280
UDI-Public10886982156280
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number219.98
Device Catalogue Number219.98
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/13/2021
Supplement Date Received by Manufacturer09/10/2021
Initial Report FDA Received Date09/10/2021
Supplement Report FDA Received Date10/07/2021
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
2.7/3.5 VA ANT/MED DSTL TIB PL/12H/LT-S.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: 4.0 MM CANNULATED.; UNK - SCREWS: 4.0 MM CANNULATED.; UNK - SCREWS: LOCKING: VARIABLE ANGLE.; UNK - SCREWS: LOCKING: VARIABLE ANGLE.; UNK - SCREWS: LOCKING: VARIABLE ANGLE.; UNK - SCREWS: LOCKING: VARIABLE ANGLE.; UNK - SCREWS: LOCKING: VARIABLE ANGLE.; UNK - SCREWS: LOCKING: VARIABLE ANGLE.; UNK - SCREWS: LOCKING: VARIABLE ANGLE.; UNK - SCREWS: METAPHYSEAL.; UNK - SCREWS: METAPHYSEAL.; WASHER 7.0MM.; 2.7/3.5 VA ANT/MED DSTL TIB PL/12H/LT-S; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 4.0 MM CANNULATED; UNK - SCREWS: 4.0 MM CANNULATED; UNK - SCREWS: LOCKING: VARIABLE ANGLE; UNK - SCREWS: LOCKING: VARIABLE ANGLE; UNK - SCREWS: LOCKING: VARIABLE ANGLE; UNK - SCREWS: LOCKING: VARIABLE ANGLE; UNK - SCREWS: LOCKING: VARIABLE ANGLE; UNK - SCREWS: LOCKING: VARIABLE ANGLE; UNK - SCREWS: LOCKING: VARIABLE ANGLE; UNK - SCREWS: METAPHYSEAL; UNK - SCREWS: METAPHYSEAL; WASHER 7.0MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Weight136
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