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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM FIXED ANGLE DRILL GUIDE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM FIXED ANGLE DRILL GUIDE Back to Search Results
Model Number 03.127.001
Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Device available for evaluation: complainant part is not expected to be returned for manufacturer review /investigation.Initial reporter occupation: reporter is a j&j sales representative.Device evaluated by mfr: 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 conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 an unknown date, on an unknown procedure, the (1) depth gauge for small screws, (2) protection sleeve/ 11/8, (2) drill sleeve / 4.2mm, (2) screwdriver shaft sddrive 165mm, (6) 2.8mm fixed angle drill guide, (3) 7.3mm cannulated screw 32mm thread/140mm, (1) scr rack 6.5 ti&ss cann scrs-16/32 thrds, (1) lckng attach washer tray rfn-advanced, (2) 2.4 va 2-clmn vlr drp 7h hd/3h sft/rt-s, and (2) 2.4 va 2-clmn vlr drp 7h hd/3h sft/lt-s have an unknown allegation.Fixed angle guides don't fit into va locking holes, screws were stripped in process.There was no known hospital or patient involvement.This complaint involves twenty-two (22) devices.This report is for (1) 2.8mm fixed angle drill guide.This report is 8 of 13 for (b)(4).
 
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Brand Name
2.8MM FIXED ANGLE DRILL GUIDE
Type of Device
GUIDE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key12063562
MDR Text Key264506124
Report Number2939274-2021-03207
Device Sequence Number1
Product Code FZX
UDI-Device Identifier10886982075017
UDI-Public(01)10886982075017
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03.127.001
Device Catalogue Number03.127.001
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/01/2021
Initial Date FDA Received06/24/2021
Supplement Dates Manufacturer Received07/22/2021
Supplement Dates FDA Received07/22/2021
Patient Sequence Number1
Treatment
2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S; 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/RT-S; 7.3MM CANNULATED SCREW 32MM THREAD/140MM; DEPTH GAUGE FOR SMALL SCREWS; DRILL SLEEVE / 4.2MM; LCKNG ATTACH WASHER TRAY RFN-ADVANCED; PROTECTION SLEEVE/ 11/8; SCR RACK 6.5 TI&SS CANN SCRS-16/32 THRDS; SCREWDRIVER SHAFT SDDRIVE 165MM
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