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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 Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter is synthes sales representative. The depth gauge for 2. 0mm and 2. 4mm screws (part #: 319. 006, lot #: h663676) was returned and received at us cq. Upon visual inspection, it was observed that the needle component was broken and was not returned. The device was also missing the protection sleeve component. No other issues were identified with the returned device. The complaint was confirmed as the needle component was broken and the device was missing the protection sleeve. There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined. However, it is possible the device encountered unintended forces during use and the missing component of the device might be misplaced when taken apart for sterilization. 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 #: h663676, supplier lot #: h663676, release to warehouse date: 06-mar-2019, supplier: (b)(4). 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, on an unknown date, the depth gauge for 2mm and 2. 4mm screws was found to have a missing piece. There were no patient and surgical 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 Key10665314
MDR Text Key211034705
Report Number2939274-2020-04614
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 09/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2020
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 NumberH663676
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2019
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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