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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 2.7MM & SMALL SCREWS GAUGE, DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.7MM & SMALL SCREWS GAUGE, DEPTH Back to Search Results
Model Number 319.01
Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter is synthes sales representative. 510k: premarket submission number not available/not released. 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. Device was used for treatment, not diagnosis. If additional information is made available, the investigation will be updated as applicable.
 
Event Description
It was reported that on an unknown date, while inspecting the instruments after going through the decontamination process, it was discovered that some instruments were damaged. The star drive screwdriver shaft is bent and wobbles in the screwdriver handle, wire guide sleeve won't fully insert into the blade guide, blade/screw guide sleeve will not let the blade inserter engage the rifling properly, tube part of depth gauge for screws is bent and will not let the screw down piece engage the threads, the insertion guide was bent and the sleeves were unable to be inserted full. However, it was set aside and inadvertently placed in the sharps container by the staff and was unable to be retrieved. There was no patient involvement with any of these items. This complaint involves five (5) devices. Concomitant products: depth gauge for screws ø 2. 7 to 4. 0 mm, measuring range up to 60 mm, 3. 2mm wire guide sleeve. Blade/screw guide sleeve. Depth gauge for screws ø 2. 7 to 4. 0 mm, insertion guide. This report is for one (1) depth gauge for 2. 7mm & small screws. This report is 4 of 5 for (b)(4).
 
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Brand NameDEPTH GAUGE FOR 2.7MM & SMALL 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)
BRANDYWINE
1303 goshen parkway
west chester PA
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 
MDR Report Key11252025
MDR Text Key231238407
Report Number2939274-2021-00556
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number319.01
Device Catalogue Number319.01
Device Lot Number5247448
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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