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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5 TI RECON SCREW T25 SD 85-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5 TI RECON SCREW T25 SD 85-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.003.027S
Device Problem Break (1069)
Patient Problem Non-union Bone Fracture (2369)
Event Date 06/09/2022
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2022, the removal of broken nail due to nonunion. The surgery was successfully completed with no delay. No fragments were generated. There is no further information. This report is for one (1)6. 5 ti recon screw t25 sd 85-sterile. This is report 5 of 5 for complaint (b)(4).
 
Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation. 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.
 
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Brand Name6.5 TI RECON SCREW T25 SD 85-STERILE
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 MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kate karberg
1302 wright lane east
west chester 19380
3035526892
MDR Report Key14950276
MDR Text Key295474130
Report Number2939274-2022-02508
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982081582
UDI-Public(01)10886982081582
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.003.027S
Device Catalogue Number04.003.027S
Device Lot Number38P7372
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/07/2022 Patient Sequence Number: 1
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