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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: PFN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH UNK - NAILS: PFN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Break (1069)
Patient Problems Pain (1994); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown pfn nail/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
This report is being filed after the review of the following journal article: tinner, c. , beckmann, n. A. , and bastian, j. D. (2020), lateral cortical notching in revision of a subtrochanteric fracture nonunion with breakage of a cephalomedullary nail, journal of orthopaedic case reports, vol. 10 (6), pages 5-8 ((b)(6)). This study presents a case report of an (b)(6) year-old female patient who sustained multifragmentary intertrochanteric fracture with subtrochanteric extension and mild preexisting hip osteoarthritis. Two days later, an open reduction and osteosynthesis with a cephalomedullary nail (proximal femoral nail antirotation®, pfn-a 125°, depuy synthes, raynham, massachusetts, usa), with cerclage of the trochanter minor was performed. One-week post-surgery, the patient was discharged to rehabilitation center with allowed full weight-bearing with a walking frame. Further 2 weeks later, the patient suffered from immediate aggravation of pain without a previous event. A radiographic control showed an articular cutout of the blade and revision surgery was undertaken with implant removal and exchange nailing using (proximal femoral nail®, pfn 125°, depuy synthes, raynham, massachusetts, usa) and application of demineralized bone matrix (from competitor and dbx®, j&j medical devices, new brunswick, new jersey, usa). At the 1-year follow-up, the patient was satisfied and only felt pain in stress situations (e. G. , home trainer activity). A balanced gait was possible with the use of a walking frame. On the radiographs, progressive consolidation with unchanged position of the nail was noted. No more follow-up visitations were planned at another institution. Four and a half years post-revision surgery, the patient immediately felt exacerbation of pain on the right hip and was admitted to our institution for the 1st time. The subsequent radiographs and computed tomography revealed a non-union with nail fatigue breakage, no signs for osteoarthritis nor any damage noted to the joint by the cutout. Revision surgery was scheduled after septic non-union was ruled out with exchange nailing using a cement augmented cephalomedullary nail (pfn 125°, depuy synthes, raynham, massachusetts, usa) by the senior author. The fracture healed uneventfully after revision at our institution with exchange nailing including the lateral cortical notching technique whilst applying osteoinductive supplements. This report is for an unknown synthes pfna blade, unknown synthes pfn 125° constructs, unknown synthes dbx, and unknown synthes pfn 125° nails. This is report 1 of 3 for (b)(4).
 
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Brand NameUNK - NAILS: PFN
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12342373
MDR Text Key267267648
Report Number8030965-2021-06844
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/19/2021 Patient Sequence Number: 1
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