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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES HAGENDORF HELICAL BLADE/SCREW EXTRACTOR ROD, FIXATION, INTRAMEDULLARY

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SYNTHES HAGENDORF HELICAL BLADE/SCREW EXTRACTOR ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.030
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/04/2016
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. (b)(6). Device is an instrument and is not implanted/explanted. The subject device is currently undergoing investigation; the results are pending completion. A device history record review was performed for the subject device lot. Manufacturer: synthes (b)(4). Date of manufacture: mar 19, 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 is reported patient was implanted with the proximal femoral nailing system (tfna) on unknown date at a different facility by a different surgeon for compression of a femoral head fracture. As the fracture compressed over time, the helical blade began to protrude beyond the bone, causing the patient discomfort. Patient was returned to surgery on (b)(6) 2016 for retraction of the helical blade. As surgeon was completing final tightening on the helical blade, it is reported he felt some resistance, and then turned the helical blade extractor one more turn. In doing so, the tip of the helical blade extractor broke off into the end of the helical blade. The fragment was not retrieved and remains embedded in the implanted helical blade. Helical blade was not retracted. The surgery was completed successfully with no delay and no further harm to patient. The helical blade retraction is addressed in related complaint (b)(4). This complaint addresses the helical blade extractor breakage. Concomitant devices reported: helical blade (part number unknown, lot number unknown, quantity 1). This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. A product development investigation was performed for the subject device. This complaint is confirmed. Upon visual inspection, the complaint condition is confirmed as the distal tip has sheared off from the rest of the device and was not returned. The balance of the device is in fair condition with minimal signs of wear and tear. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken. A visual inspection under 5x magnification and drawing review were performed as part of this investigation. No product design issues or discrepancies were observed. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. The returned implant is part of the depuy synthes tfn advanced (tfna) proximal femoral nailing system. The helical blade/screw extractor is used to remove an implanted helical blade/screw (per technique guide). A review of the current design drawing was performed. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. Unable to determine a definitive root cause. Most likely due to application of excessive force during threading/insertion into the implanted helical blade due to bony ingrowth around the helical blade. 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 NameHELICAL BLADE/SCREW EXTRACTOR
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 Key6132795
MDR Text Key61059766
Report Number3003875359-2016-10620
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 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.030
Device Lot Number9376543
Other Device ID Number(01)10886982070463(10)9376543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2015
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: 11/29/2016 Patient Sequence Number: 1
Treatment
UNKNOWN (TFNA) HELICAL BLADE, QTY 1
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