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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 03.037.010
Device Problem Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 06/07/2018
Event Type  Injury  
Manufacturer Narrative
Patient information is unknown. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested. 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 there was difficulty removing the insertion handle from the trochanteric fixation nail advanced (tfna) nail during a trochanteric fixation nail advanced (tfna) procedure on (b)(6) 2018. The surgeon had to chisel away the top of the connecting screw to get the screw out, which extended the surgery by ten (10) minutes. The patient was reported to be doing fine at the end of the surgery. This is report 1 of 3 for (b)(4).
 
Manufacturer Narrative
Device history records review was completed for part# 03. 037. 010, lot# l713166. Manufacturing location: (b)(4), release to warehouse date: mar 13,2018. The device history record shows this lot of devices was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted. This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Product development investigation was completed. The cannulated connecting screw was received with deformation at the hex end recess. The tip of the recess was observed to have been chipped. Additionally, scratches on the surface of the device was observed, which would not contribute to the reported condition. Based on the visual inspection, the complaint is confirmed for deformation to the hex end recess, however the reported complaint condition cannot be confirmed as the mating device was not returned for testing. A functional test could not be replicated at us customer quality as the mating device was not returned. Dimensional analysis was performed after slotting and were within specifications. The outer diameter at the hex end measured at 12. 94mm, which is within specifications of 13 0/-0. 1mm per the drawing. The hex recess was received with post manufacturing damage; thus, a dimensional analysis is not applicable. Relevant drawings were reviewed during the investigation. While no definitive root cause could be determined, it is possible that the device encountered excessive force/torque when it is being disconnected from the insertion handle/nail, which could contribute to the complaint condition of unable to disassemble from the insertion handle. The reported complaint condition is unconfirmed as the mating device was not returned, however the complaint is confirmed for deformation to the hex recess which would contribute to the complaint condition. During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition. 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.
 
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Brand NameCANNULATED CONNECTING SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key7659079
MDR Text Key113041239
Report Number2939274-2018-52702
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.010
Device Catalogue Number03.037.010
Device Lot NumberL713166
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/03/2018 Patient Sequence Number: 1
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