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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.003.029S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/15/2021
Event Type  malfunction  
Manufacturer 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 history lot - a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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) 2021, patient underwent a surgical procedure due to a gunshot wound with a non displaced basalar neck fracture. The patient had suffered a gunshot wound to the hip with a non displaced basalar neck fracture that extended into the trochanteric area. The surgeon had originally planned to go with a tfna, and elected to go with a femoral recon nail because of the patients' smaller stature and age. I advised that the frn was not indicated for trochanteric type fractures, but ultimately the surgeon elected to use the nail. During the case, the 3. 2 guide pin for the recon screw missed the nail on initial entry; however it was determined that soft tissue was binding on the sleeve. The sleeves were readjusted, the guide pins and screws were inserted properly. Ultimately there were no allegations against the devices or adverse events. Procedure was completed successfully without any surgical delay. No patient consequence. Concomitant devcie reported: unk - guides/sleeves/aiming: aiming arm (part# unknown; lot# unknown; quantity: 1. This report is for one (1) 6. 5mm ti recon screw with t25 stardrive 95mm-sterile. This is report 2 of 5 for complaint (b)(4).
 
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Brand Name6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM-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
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12318344
MDR Text Key266393948
Report Number2939274-2021-04636
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040336
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 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.003.029S
Device Catalogue Number04.003.029S
Device Lot NumberL490510
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 Received07/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2017
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: 08/13/2021 Patient Sequence Number: 1
Treatment
3.2MM GUIDE WIRE 400MM; 6.5 TI RECON SCREW T25 SD 85-STERILE; 6.5 TI RECON SCREW T25 SD 95-STERILE; 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING; 9 / TI CANN FRN / GT 340 / LEFT - SILE; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING: SLEEVE
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