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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
Catalog Number 319.006
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
F the information is unknown, not available or does not apply, the section/field of the form is left blank. Device history records review was completed for part: ,319. 006, lot: ft00388. Supplier: (b)(4), release to warehouse date: mar 02, 2017. No non conformance reports were generated during production. The material was reviewed and the hardness value was confirmed to meet the specification with no relevant non-conformance noted. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Product investigation was completed. Visual inspection observed broken needle on the returned depth gauge. The broken needle portion was not returned at customer quality. However, all other portions of depth gauge i. E. ; protection sleeve, body and slider were returned. No other issues were identified on the remaining portions of the device except for the signs of wear that doesn't affect product functionality. The device condition agree with the complaint description and the complaint was confirmed. Relevant drawings for the returned device were reviewed, and no design issues were noted. Dimensional inspection was not possible as the relevant broken portion was not returned. While no definitive root cause could be determined, it is possible that any unintended excessive forces such as device being dropped during usage/handling could have contributed to complaint condition. The overall complaint condition was confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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 (b)(6) 2018, while inspecting the instruments before putting the sets back together, it was found that the tip of the depth gauge was broken and missing. It is unknown how the device issue occurred. There was no patient involvement as reported. This report is for one (1) depth gauge. 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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key8027955
MDR Text Key125777469
Report Number2939274-2018-54730
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
Report Date 09/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number319.006
Device Lot NumberFT00388
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/02/2017
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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