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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 Problems Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: investigation flow: damage. Visual inspection: the depth gauge for 2. 0mm and 2. 4mm screws (part# 319. 006, lot# h786310, qty# 1) was received at us cq. Upon visual inspection at cq, it is observed that the needle part got deformed at the distal tip. Rest of the surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition. Thus, the complaint is being confirmed. Device failure/ defect found? yes. Dimensional inspection (calipers: ca122p): dimensional inspection of the received device was performed at cq. The diameter of the needle near to the bent location was intended to be measuring from 1. 20mm to 1. 25mm and it was measured to be 1. 22mm which is within specification. Documentation/ specification review: no design issues or discrepancies were found during this investigation. Complaint confirmed? yes. Investigation conclusion: the complaint is being confirmed for depth gauge for 2. 0mm and 2. 4mm screws (part# 319. 006, lot# h786310) as it is observed that the needle part got deformed at the distal tip. A definitive root cause could not be determined for the reported problem, but there is high possibility that the needle component might have encountered unintended forces. During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Device history lot: part # 319. 006. Synthes lot # h786310. Supplier lot # h786310. Release to warehouse date: dec 20, 2019. Supplier: avalign technologies nemcomed. No ncr's were generated during production. Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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 during a routine incoming inspection of a loaner set at fsl ups (b)(6) site on an unknown date, the depth gauge for 2. 0mm and 2. 4mm screws was observed bent. There were no patient and surgical involvement. This complaint involves 2 devices. This report is for (1) depth gauge for 2. 0mm and 2. 4mm screws. This is report 1 of 2 for (b)(4).
 
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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 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10804650
MDR Text Key215285839
Report Number2939274-2020-04999
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2020
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 NumberH786310
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2019
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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