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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 Discolored (1170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Reporter is a synthes employee. Part: 319. 006, synthes lot: 6188417, supplier lot: na, release to warehouse date: july 30, 2009, manufactured by synthes (b)(4). No nonconformance reports (ncrs) 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 was received at us customer quality (cq). Upon visual inspection, the needle was bent and the device was found to have surface scratches and minor discoloration. Dimensional inspection: measured dimensions: needle shaft od: conforming. Document/specification review: current and manufactured revisions were reviewed. No design issues or discrepancies were identified. Investigation conclusion: this complaint is confirmed as the visual inspection of the complaint device revealed bent needle, surface scratches and discoloration. No definitive root cause could be determined based on the provided information. 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 preventive 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 during inspection of back up items on unknown date, some were set aside for expired exchange. One (1) bending pliers have no tension. Two (2) topcoat from the depth gauges are peeling. One (1) handle with quick coupling gets stuck. One (1) universal drill guide has pitting on the handle. One (1) stardrive screwdriver is losing its shape. And two (2) socket wrenches have pitting on the swivel. There was no patient involvement. This report is for a depth gauge for 2. 0mm and 2. 4mm screws. This is report 2 of 3 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)
BRANDYWINE
1303 goshen parkway
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11792057
MDR Text Key249542731
Report Number2939274-2021-02262
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 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
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 Number6188417
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/07/2021 Patient Sequence Number: 1
Treatment
2.0MM UNIVERSAL DRILL GUIDE; 2.4/2.7MM VA-LCP BENDING PLIER; HANDLE WITH QUICK COUPLING, SMALL; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SOCKET WRENCH-11MM WIDTH ACROSS FLATS
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