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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES HAGENDORF CANNULATED CONNECTING SCREW ROD, FIXATION, INTRAMEDULLARY

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SYNTHES HAGENDORF CANNULATED CONNECTING SCREW ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.010
Device Problems Failure To Adhere Or Bond (1031); Dull, Blunt (2407)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
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. Manufacturing location: (b)(4). Manufacturing date: september 24, 2015. No non-conformance reports were generated during production. 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. 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 a routine set inspection the threads on the connecting screw were found to be stripped and will not engage properly. There is no case or patient involvement. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. One (1) cannulated connecting screw (part 03. 037. 010, lot 9518512, mfg 24-sep-2015) was returned with a complaint stating that the threads of the connecting screw were found to be stripped and not engaging the nail properly. A visual inspection and drawing review were performed as part of this investigation. The complaint was able to be confirmed at customer quality as the most distal threads were visibly rolled and damaged. Replication of the complaint is not applicable as the device was visibly deformed. Relevant product drawing was reviewed during the investigation. No drawing issues or discrepancies were noted. The design is adequate for its intended use and did not contribute to this complaint condition. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The cannulated connecting screw is part of the depuy synthes tfnadvanced (tfna) proximal femoral nailing system. The system is utilized for the intramedullary fixation of proximal femoral fractures. The instrument aids in the insertion of the titanium nail (per technique guide). No definitive root cause was able to be determined. Soft tissue pressure on the insertion handle leads to angle error on the axis between the nail and the insertion handle which inhibit the loosening and removal of the connection screw. This may contribute to thread stripping of the connecting screw. Additionally, off angle insertion and excessive force during insertion or removal may have contributed to the damaged threads of the connecting screw. 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)
SYNTHES HAGENDORF
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer (Section G)
SYNTHES HAGENDORF
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5963812
MDR Text Key55159433
Report Number3003875359-2016-10500
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
Type of Report Initial,Followup
Report Date 09/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.010
Device Lot Number9518512
Other Device ID Number(01)10886982070265(10)9518512
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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