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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.160S
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2017
Event Type  malfunction  
Manufacturer Narrative
Complained part is not expected to be received for investigation; however, the concomitant drill bit was received on december 07, 2017. 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
A device history record (dhr) review was performed for part # 04. 037. 160s, lot#: h360438 (sterile) - 11mm/130 deg ti cann tfna 400mm / right - sterile. Quantity 6. : manufacturing location: (b)(4), manufacturing date: 09-may-2017, expiration date: 30-apr-2027: component parts reviewed: part 04. 037. 942. 2 - lock prong, 130 degree, tfna bp-55 lot ¿ l357740, part 04. 037. 912. 4 - wave spring, shim ended bp-55 lot ¿ h249488, part 04. 037. 912. 3 - tfna lock drive bp-58 lot ¿ h346358: part 21127 - raw material lot bp-80 lot ¿ h188690. Raw material received from (b)(6) company. Certified test report received from (b)(6) and certificate of test received for titanium ingot meet specification. Raw material receiving/putaway checklist meet requirements. Inspection sheet for tfna assembly inspection and inspection sheet for in-process/inspect dimensional/final ns063045 rev: j met inspection acceptance criteria. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Sterility documentation was reviewed and determined to be conforming. Product was not returned. Based on the information available, 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. 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
Additional patient¿s identifier: (b)(6). Patient¿s weight is unknown. Explanted date: not explanted, remained implanted. Complainant device is not expected to be returned for manufacturer review/investigation. 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 during an intramedullary (im) nailing of a trochanteric fracture of a hip using a trochanteric fixation nail-advanced (tfna) on (b)(6) 2017, a metal fragment was seen on the x-ray image after drilling, but before helical blade insertion. Drilling for the helical blade placement was smooth and the surgeon experienced no issues and did not have any resistance. To the surgeon¿s knowledge he did not hit the nail with the drill bit during drilling. After he removed the drill bit and before helical blade placement an intraoperative x-ray was taken which revealed a metal fragment. The surgeon was not sure where it came from. The x-ray image was not saved and is not available for review. The surgeon did not attempt to remove the fragment, as it was not a concern for patient¿s harm. The surgeon did inspect the drill bit and there was no visible damage noted to the drill bit. After the helical blade insertion, the nail set screw was able to be turned a quarter of a turn to lock the helical blade in place and again this was performed without incident. There was a later x-ray taken but due to the angle of the image the fragment is not visible. Procedure completed successfully without any surgical delay. Patient outcome reported as stable. Concomitant devices reported: tfna helical blade 100mm sterile (part # 04. 038. 300s, lot # unknown, quantity 1) 6mm/9mm cannulated stepped drill bit (part # 03. 037. 022, lot # f-19283, quantity 1). This report is for one (1) 11mm/130 deg ti cann tfna 400mm/right - sterile. This is report 1 of 1 for complaint (b)(4).
 
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Brand Name11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE
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 michael
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7082488
MDR Text Key254929755
Report Number2939274-2017-50140
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.160S
Device Catalogue Number04.037.160S
Device Lot NumberH360438
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 Received01/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/09/2017
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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