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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES INSTRUMENT,CUTTING,ORTHOPAEDIC

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES INSTRUMENT,CUTTING,ORTHOPAEDIC Back to Search Results
Model Number 03.130.271
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Reporter is company representative. Device deemed reportable on march 23, 2020. Investigation summary: visual inspection: the plate cutter for 1. 3mm/1. 5mm and 2. 0mm plates (p/n: 03. 130. 271, lot number: t164174) was received at us cq. Upon visual inspection, the jaw edges were deformed, and the silicone plate holder inserts were missing. Device failure/defect identified? yes. Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage. Document/specification review: no design issues or discrepancies were identified. Complaint confirmed? yes. Investigation conclusion: this complaint is confirmed as the jaw edges are deformed and the silicone plate holder inserts are 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 history: part number: 03. 130. 271. Lot number: t164174. Manufacturing site: (b)(4). Release to warehouse date: 11-dec-2018. A review of the device history records was performed for the finished device lot number, and no non-conformances 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 during a routine incoming inspection of a loaner set on an unknown date, the plate cutter was observed damaged. There were no patient and surgical involvement. This is report 1 of 1 for (b)(4).
 
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Brand NamePLATE CUTTER FOR 1.3MM/1.5MM AND 2.0MM PLATES
Type of DeviceINSTRUMENT,CUTTING,ORTHOPAEDIC
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9961837
MDR Text Key187899715
Report Number2939274-2020-01829
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 Other Health Care Professional
Type of Report Initial
Report Date 02/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.130.271
Device Catalogue Number03.130.271
Device Lot NumberT164174
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2018
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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