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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CUTTER FOR TI ELASTIC NAILS INSTRUMENT, CUTTING, ORTHOPEDIC

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC CUTTER FOR TI ELASTIC NAILS INSTRUMENT, CUTTING, ORTHOPEDIC Back to Search Results
Model Number 359.217
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2020
Event Type  malfunction  
Manufacturer Narrative
Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(6) 2020, the cutter for titanium elastic nails was broken, two (2) 2. 7mm reaming rod pusher 450mm long and one (1) helical blade/screw measuring device piece were broken off. While, the stardrive screwdriver shaft t25 3. 5mm hexagonal/self-retain and cannulated 3. 5mm hexagonal screwdriver shaft head were stripped. There was a surgical delay of a couple of minutes. Fragments were generated and instruments were removed. It is unknown if procedure was successfully completed. There is patient involvement. This is report 1 of 5 for (b)(4).
 
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Brand NameCUTTER FOR TI ELASTIC NAILS
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)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10928601
MDR Text Key218987124
Report Number2939274-2020-05379
Device Sequence Number1
Product Code HTZ
UDI-Device Identifier10886982197153
UDI-Public(01)10886982197153
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 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number359.217
Device Catalogue Number359.217
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/01/2020 Patient Sequence Number: 1
Treatment
2.7MM REAMING ROD PUSHER 450MM LONG; 2.7MM REAMING ROD PUSHER 450MM LONG; CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT; HELICAL BLADE/SCREW MEASURING DEVICE
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