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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH Back to Search Results
Model Number 319.006
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2022
Event Type  malfunction  
Event Description
It was reported that on (b)(6) 2022 during elbow surgery wire dip stick of the depth gauge broke off inside the bone while measuring. The fragment was retrieved. A different depth gauge was acquired. Procedure was completed successfully with a surgical delay of 1 minute. This report is for one (1) depth gauge for 2. 0mm and 2. 4mm screws. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. 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 NameDEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
Type of DeviceGAUGE,DEPTH
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
Manufacturer Contact
kate karberg
eimattstrasse 3
oberdorf 
SZ  
3035526892
MDR Report Key14168123
MDR Text Key290467622
Report Number2939274-2022-01435
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number319.006
Device Catalogue Number319.006
Device Lot NumberFT00443
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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