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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES HAGENDORF HYBRID INSERTION HANDLE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES HAGENDORF HYBRID INSERTION HANDLE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.011
Device Problems Fitting Problem (2183); Dull, Blunt (2407)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2017
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. The subject device has been received and is currently in the evaluation process. A device history record review was performed for the subject device lot. Manufacturer: synthes (b)(4). Date of manufacture date: jul 23, 2015. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. 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 initial surgery to treat a proximal femur fracture on (b)(6) 2017 the driving cap would not thread properly into the insertion handle. Reportedly, both devices are stripped. Another similar instrument was not available. The surgeon was able to insert the nail far enough by hand without hammering. The surgery was successfully completed. There was no surgical delay or patient harm. The patient outcome was stable. This report is 1 of 1 for com-(b)(4).
 
Manufacturer Narrative
A product investigation was completed: one insertion handle (part 03. 037. 011, lot 9518656) was returned with a complaint of striped alleged against it. The device is in a like new condition without any visible damage or deficiency. A functional test with a known conforming mating instrument (part 03. 010. 523, lot 9065795) found that the devices were able to properly assemble without any issues. No product design issues or discrepancies were observed. This complaint condition is unconfirmed. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. A visual inspection, functional test, and drawing review were performed as part of this investigation. Per the technique guide, the instrument(s) are used during femoral nail implantations and proper use and maintenance are addressed in technique guides. The returned devices are multi use and are used for implanted nails. A 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. There were no issues found with the returned device, and the device functioned as designed. No root cause was identified for the insertion handle as the complaint condition could not be replicated. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. The returned parts were determined to be suitable for the intended use when employed. 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 NameHYBRID INSERTION HANDLE
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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6405040
MDR Text Key69949603
Report Number3003875359-2017-10113
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 02/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.011
Device Lot Number9518656
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2015
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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