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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 Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Part # 319. 006, synthes lot # h663677, supplier lot # h663677, release to warehouse date: 07 mar 2019, supplier: avalign technologies-nemcomed, no ncr's were generated during production. 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. Visual inspection: the depth gauge for 2. 0mm and 2. 4mm screws (p/n: 319. 006, lot #: h663677) was received with the needle component broken from the slider. The transverse fracture of the needle is located at the interface between the needle and slider. The distal portion of the needle was observed to be bent off-axis. The protection sleeve component is missing. No other issues were identified. Device failure/defect identified? yes. Dimensional inspection: specified dimensions: needle diameter
=
conforming. Document/specification review: -depth gauge for 2. 0/ 2. 4mm screws. -protection sleeve. -needle. Complaint confirmed? yes. Investigation conclusion: this complaint is confirmed as the needle component was broken from the slider. The transverse fracture of the needle is located at the interface between the needle and slider. The distal portion of the needle was observed to be bent off-axis and missing protection sleeve. No new, unique or different patient harms were identified as a result of this evaluation. There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. 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 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, during routine incoming inspection of loaner set it was observed that the depth gauge was damaged/bent. There was no patient involvement. This report is for one (1) depth gauge for 2. 0mm and 2. 4mm screws this is report 1 of 1 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 Key9912279
MDR Text Key186134234
Report Number2939274-2020-01661
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 Other Health Care Professional
Type of Report Initial
Report Date 03/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2020
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 NumberH663677
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2019
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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