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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE/ROD CUTTER INSTRUMENT, CUTTING, ORTHOPEDIC

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE/ROD CUTTER INSTRUMENT, CUTTING, ORTHOPEDIC Back to Search Results
Model Number 391.990
Device Problems Difficult to Open or Close (2921); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A product investigation was conducted. Visual inspection: the plate/rod cutter (product code: 391. 990 & lot no: t160451) was received at us cq. The visual inspection of the received device indicated that the cutting edges were dull and slightly deformed on both jaws. No other damages were observed on the device. Functional test: the functional test performed on the complaint device indicated that the jaws and handles of the device were not completely open when handles decompressed or released. This functional failure was consistent with the reported condition, thus the complaint was confirmed. The complaint can be replicated with the returned device(s) dimensional inspection: the dimensional inspection was not performed as it is irrelevant to the reported functional failure and also due to post-manufacturing damage of the jaws cutting edges. Document/specification review: the relevant drawing reflecting current and manufactured revision was reviewed: investigation conclusion: the overall complaint was confirmed for the received device as the device was not functioning as intended. While no definitive root cause could be determined based on the provided information, it is possible that the low spring temper or poor lubrication caused this functional failure of the device. The deformed cutting edges failure may be caused due to the excessive force. 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. Part number: 391. 990, lot number: t160451, manufacturing site: (b)(4), release to warehouse date: 15-aug-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
Veterinary complaint: it was reported that on an unknown date during an unknown case it was discovered that the plate rod cutter are not springing back open after use. These cutters primarily used with tibial plateau leveling osteotomy (tplo) and to cut the threaded pin for standard jig. No further information provided. During manufacturer's investigation of the returned device it was identified that the cutting edges were dull and slightly deformed on both jaws. This device condition was reassessed and determined as reportable on (b)(6) 2020. Concomitant devices reported: kirschner wire (part # vw3005. 15, lot # unknown, quantity unknown). This report is for 1 plate/rod cutter. This is report 1 of 1 for (b)(4).
 
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Brand NamePLATE/ROD CUTTER
Type of DeviceINSTRUMENT, CUTTING, ORTHOPEDIC
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 Key10329360
MDR Text Key200619501
Report Number2939274-2020-03305
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number391.990
Device Catalogue Number391.990
Device Lot NumberT160451
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2018
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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