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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE SHORT CUT PLATE CUTTER 03.503.057

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE SHORT CUT PLATE CUTTER 03.503.057 Back to Search Results
Model Number 03.503.057
Device Problem Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Reporter company employee. A product investigation was conducted. Visual inspection: the matrixmandible short cut plate cutter (p/n: 03. 503. 057, lot number: l259491) was received at us cq. Upon visual inspection, the cutting head jaws are deformed. Dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage. Document/specification review: relevant drawings were reviewed. No design issues or discrepancies were identified. Investigation conclusion: this complaint is confirmed the cutting head jaws are deformed. 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. A device history record (dhr) review was conducted: part: 03. 503. 057. Lot: l259491. Manufacturing site: (b)(4). Release to warehouse date: 10. Feb. 2017. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. 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, during routine incoming inspection of loaner set it was observed that the matrixmandile short cut plate cutter was damaged. There was no patient involvement. During manufacturer's investigation of the returned device it was identified that the cutting head jaws are deformed. This product condition was reassessed and determined to be reportable on april 3, 2020. This report is for one (1) matrixmandible short cut plate cutter. This is report 1 of 1 for (b)(4).
 
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Brand NameMATRIXMANDIBLE SHORT CUT PLATE CUTTER
Type of Device03.503.057
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9988199
MDR Text Key188579548
Report Number2939274-2020-02002
Device Sequence Number1
Product Code HTZ
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
Type of Report Initial
Report Date 03/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.503.057
Device Catalogue Number03.503.057
Device Lot NumberL259491
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2017
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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