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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 170MM - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.042S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2018
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. 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) 2018, during a revision surgery of a trochanteric femoral nailing advanced (tfna) system, the surgeon had difficulty locking the tfna screw to the nail. The surgeon inserted the lag screw to the nail and locked the set screw in the nail. Then when he tried to rotate the lag screw, he was only able to rotate it 180 degrees. The steps were repeated, and the set screw was finally locked. It is unknown if there were any surgical delays. The procedure was successfully completed. The patient outcome is unknown. Concomitant devices reported: locking screw (part# 04. 005. 528s, lot# unknown, qty 1); tfna screw 95mm (part# 04. 038. 095s, lot# unknown, qty 1); this report is for one (1); 10mm/130 deg ti cann tfna 170mm - sterile. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. Initial reporter: state and country code. 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.
 
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Brand Name10MM/130 DEG TI CANN TFNA 170MM - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8139384
MDR Text Key129574911
Report Number2939274-2018-55312
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982095985
UDI-Public(01)10886982095985
Combination Product (y/n)N
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.042S
Device Catalogue Number04.037.042S
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2018
Is This a Reprocessed and Reused Single-Use Device?

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