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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T GAUGE, DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T GAUGE, DEPTH Back to Search Results
Catalog Number 319.006
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Device report from synthes reports an event in the usa as follows: product code: 319. 006, product name: depth gauge for 2. 0mm and 2. 4mm screws, lot number: ft00443. It was reported that physical finding of the device is broken. This report is for one (1) depth gauge f/scr ø2+2. 4 meas-range up-t. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter is a j&j employee. Device history lot: part # 319. 006, synthes lot # ft00443, supplier lot # ft00443, release to warehouse date: 15 may2017, supplier: (b)(4). No ncrs were generated during production. Note: ri information was retrieved from (b)(4), as it is the same lot number and lot number name device history 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. Investigation summary: product code: 319. 006, product name: depth gauge for 2. 0mm and 2. 4mm screws, lot number: ft00443. The product was returned to depuy synthes for evaluation. The depuy synthes team conducted a visual inspection of the returned device. Visual analysis of the returned sample revealed that the depth gauge f/scr ø2+2. 4 meas-range up-t had the needle broken, fragment is not included in the package. A dimensional inspection for the depth gauge f/scr ø2+2. 4 meas-range up-t and was unable to be performed due to post manufacturing damage. The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces. As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications. The overall complaint was confirmed as the observed condition of the depth gauge f/scr ø2+2. 4 meas-range up-t would contribute to the complained device issue. There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined. 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.
 
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Brand NameDEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T
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
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14051637
MDR Text Key288867352
Report Number2939274-2022-01229
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number319.006
Device Lot NumberFT00443
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2022
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2017
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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