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U.S. Department of Health and Human Services

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

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SYNTHES HAGENDORF PERCUTANEOUS RADIOLUCENT INSERTION HANDLE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.112
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2016
Event Type  malfunction  
Manufacturer Narrative
Device used for treatment, not diagnosis. Patient information not available for reporting. (b)(4). Device is an instrument and is not implanted/explanted. Date returned to manufacturer subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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 a cannulated connecting screw became stuck in a trochanteric fixation nail advanced (tfna) and an insertion handle could not be removed during a left intertrochanteric fracture repair on (b)(6) 2016. There was a reported fifteen (15) minute surgical delay. The procedure was completed successfully with the patient in stable condition. This complaint involves two devices concomitant devices reported: tfna (part #04. 037. 245s, lot #h146700, quantity 1). This report is 2 of 2 for (b)(4).
 
Manufacturer Narrative
(b)(4). Device history record review: manufacturing location: (b)(4); manufacturing date: 22. Oct. 2015. No ncrs 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 manufacturer investigation results are as follows. The returned insertion handle is in good condition with no issues noted. The concomitant nail was not returned, therefore the interaction between the 3 parts was unable to be tested. No ncrs 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. A visual inspection, drawing review and dhr review were performed as part of this investigation. Usage of the returned devices is outlined in the tfna proximal femoral nailing system technique guide (dsus/trm/0614/0109(2). No definitive root cause was able to be determined, as the concomitant nail was not returned and was unable to be tested with the returned parts. 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 NamePERCUTANEOUS RADIOLUCENT INSERTION HANDLE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES HAGENDORF
im bifang 6
hagendorf PA 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 Key6145798
MDR Text Key61497959
Report Number2520274-2016-15585
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 11/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.112
Device Lot Number9607179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/05/2016 Patient Sequence Number: 1
Treatment
04.037.245S, LOT #H146700, QUANTITY 1)
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