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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 12MM TI END CAP T40 STARDRIVE 10MM EXT FOR FEMORAL NAILS-EX ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 12MM TI END CAP T40 STARDRIVE 10MM EXT FOR FEMORAL NAILS-EX ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.003.002
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2017
Event Type  malfunction  
Manufacturer Narrative
Dhr review was completed. Part number: 04. 003. 002, synthes lot number: 5687067 , supplier lot number: n/a , release to warehouse date: 15-apr-2008, expiration date: n/a, manufactured by (b)(4). No ncrs were generated during production. Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition. Customer quality conducted an investigation of the returned device. Visual inspection under 5x magnification at customer quality (cq) on the returned 9+year old implant that is intended for single use only revealed post manufacturing damage in the form of damaged threads. An area on the second most distal thread and third most distal thread have dents/bent in opposite directions which suggests another metallic device was forcibly wedged into the thread form. There also exist wear marks which suggest the device has been handled with pliers or roughly in another manner. The reported complaint condition was not able to be replicated at cq via functional test because the nail involved in the event was not returned. However, the post manufacturing damage on the 9+ year old implant that is intended for single use only could cause or contribute to the reported complaint condition. Therefore, this complaint is confirmed. Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition. Tabulated drawing was reviewed during this investigation. No product design issues or discrepancies were observed. A dimensional inspection on the 9+ year old implant that is intended for single use only was not performed at cq because the post manufacturing thread damage was visually confirmed. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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.
 
Manufacturer Narrative
Patient weight is unknown. Additional product code: hwc. Due to intra-operative issues, the device was not implanted/explanted. Facility information was not provided. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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 two different 10 mm end caps would not thread into the nail during a right lateral entry femoral nail procedure on (b)(6) 2017. The surgeon had placed the 9x340 nail and went to place a 10 mm end cap in the proximal portion of the nail. He tried two different 10 mm end caps and neither would thread into the nail. He then went and placed a 15 mm end cap and had no problem getting it to engage and thread in. There was a ten (10) minute surgical delay. The surgery was successfully completed with good patient outcome. Concomitant device report: 9x340 nail (part unknown, lot unknown, quantity 1). This is report 2 of 2 for (b)(4).
 
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Brand Name12MM TI END CAP T40 STARDRIVE 10MM EXT FOR FEMORAL NAILS-EX
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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7191193
MDR Text Key273134057
Report Number2939274-2018-50266
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.003.002
Device Catalogue Number04.003.002
Device Lot Number5687067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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