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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 LOCKING SCREWS TO 100MM FOR IM NAILS GAUGE,DEPTH

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS GAUGE,DEPTH Back to Search Results
Model Number 03.010.072
Device Problems Break (1069); Component Missing (2306); Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Part: 03. 010. 072. Lot: 1774697. Manufacturing site: (b)(4). Release to warehouse date: november 15, 2007. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. The depth gauge for locking screws to 100mm for im nails (p/n: 03. 010. 072, lot number: 1774697) was received at us customer quality (cq). Visual inspection of the complaint device showed that the needle component was slightly bent near the proximal end, ball and spring components on slider assembly were missing. Device failure/defect identified? yes. Dimensional inspection: drawing. Specified dimensions: needle outer diameter at proximal end
=
2. 5 +0/-0. 1 mm. Measured dimensions: needle outer diameter near bent location
=
2. 44mm, conforming. Device used ¿ caliper ca802. Dimensional analysis on the hole for the missing ball and compression spring components could not be performed due to deformation from the staking process that happens during the final assembly. Document/specification review: current and manufactured were reviewed. Current and manufactured were also reviewed. No design issues or discrepancies were identified. Complaint confirmed? yes. Investigation conclusion: this complaint was confirmed as the device needle/hook component was bent, ball and spring components were missing. 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 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, the depth gauge was found broken during reverse logistics audit of returned device at millstone. There was no patient involvement. This report involves one (1) depth gauge for locking screws to 100mm for im nails. This is report 1 of 1 for (b)(4).
 
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Brand NameDEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS
Type of DeviceGAUGE,DEPTH
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9967259
MDR Text Key187883080
Report Number2939274-2020-01861
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 other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.010.072
Device Catalogue Number03.010.072
Device Lot Number1774697
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2007
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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