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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM; PLATE, FIXATION, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM; PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.211.012
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 unknown date, the patient underwent a surgery for removal of hardware.During the surgery, it was noted that various small screws broke off on va distal humerus plates.These screws were too difficult to remove and have been left in patient bone.It is unknown if the surgery was successfully completed.It is unknown if there was a fragment generated.Patient status is unknown.Concomitant devices reported: unk - plates: lateral va-lcp proximal tibia plate(part# unknown, lot# unknown, qty unknown).This complaint involves five (5) devices.This report is for (1) 2.7mm va lckng screw slf-tpng with t8 stardrive recess 12mm this report is 4 of 5 for (b)(4).
 
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Brand Name
2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key12349142
MDR Text Key267511910
Report Number2939274-2021-04773
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819424913
UDI-Public(01)07611819424913
Combination Product (y/n)N
PMA/PMN Number
K103243
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02.211.012
Was Device Available for Evaluation? No
Date Manufacturer Received09/21/2021
Patient Sequence Number1
Treatment
2.0 CORTEX SCREW SLF-TPNG SD RECESS 10.; 2.0 CORTEX SCREW SLF-TPNG SD RECESS 10.; 2.7 CORTEX SCREW SLF-TPNG T8 SD REC 10.; 2.7MM VA LCK SCREW SLF-TAP.; 2.7MM VA LCK SCREW SLF-TAP.; UNK - PLATES: LATERAL VA-LCP PROXIMAL TIBIA PLATE.; UNK - PLATES: LATERAL VA-LCP PROXIMAL TIBIA PLATE.; 2.0 CORTEX SCREW SLF-TPNG SD RECESS 10; 2.7MM VA LCK SCREW SLF-TAP; UNK - PLATES: LATERAL VA-LCP PROXIMAL TIBIA PLATE
Patient Age25 YR
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