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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 03.037.024
Device Problem Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The returned device was assembled with the mating device helical blade/screw coupling screw, it was noticed the it was not tightening properly due to some resistance. Hence, the complaint is confirmed. It is possibly due to the stripped condition of internal thread of the device. The exact cause of the reported condition is unknown, but, it is likely that the device was subjected to excessive forces during the 4+ year life of the device. After a visual inspection per guidance provided in windchill document # 0000277191, it is determined that the device is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required. During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities device history lot: part number: 03. 037. 024, lot number: t118565, manufacturing site: (b)(4), release to warehouse date: 14-apr-2015. A review of the device history records 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 (b)(6) 2019, during equipment check, one (1) flexible hexagonal screwdriver snapped in half due to improper handling, two (2) flexible shaft bent and un-usable, one (1) helical blade inserter, is caught in with the coupling screw and the inserter handle and won¿t advance, one (1) helical blade/screw coupling screw will not advance and therefore cannot engage the blade, they were discovered damaged in the sterile processing department. There was no patient involvement. This is 5 of 5 for report (b)(4).
 
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Brand NameHELICAL BLADE INSERTER
Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 Key9571851
MDR Text Key194623998
Report Number2939274-2020-00114
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
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 01/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.024
Device Catalogue Number03.037.024
Device Lot NumberT118565
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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