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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S PLATE,FIXATION,BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S PLATE,FIXATION,BONE Back to Search Results
Model Number 02.111.731S
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). Complainant part is not expected to be returned for manufacturer review /investigation. Reporter is a j&j sales 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 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. 4 va 2-clmn vlr drp 7h hd/3h sft/rt-s. This report is 13 of 13 for (b)(4).
 
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Brand Name2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12063571
MDR Text Key268320332
Report Number2939274-2021-03216
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083694
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number02.111.731S
Device Catalogue Number02.111.731S
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 Received07/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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