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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 3.5MM CORTEX SCREWS SURGICAL DEPTH GAUGE, REUSABLE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 3.5MM CORTEX SCREWS SURGICAL DEPTH GAUGE, REUSABLE Back to Search Results
Model Number 319.091
Device Problems Material Discolored (1170); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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 not expected to be returned for manufacturer review/investigation. Reporter is a j&j sales representative. The lot number was unknown. Therefore, the expiration date and device manufacture date were unknown. Without a lot number the device history records review could not be completed. Product was not returned. Investigation summary: 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. (b)(6).
 
Event Description
This is report 1 of 3 for (b)(4). It was reported by the sales rep that postoperatively to an unknown surgery on an unknown date, it was observed that the depth gauge devices were bent, discolored and sticking; and the fixation plate device did not attach. There were no adverse patient consequences nor surgical delay reported. No additional information was provided. This report is for one (1) depth gauge for 3. 5mm cortex screws device. This complaint involves three (3) devices.
 
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Brand NameDEPTH GAUGE FOR 3.5MM CORTEX SCREWS
Type of DeviceSURGICAL DEPTH GAUGE, REUSABLE
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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14144438
MDR Text Key290467712
Report Number2939274-2022-01374
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number319.091
Device Catalogue Number319.091
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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