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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Migration (4003)
Patient Problems Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown pfna helical blade/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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: brunner, a. , jockel, j. A. And babst, r. (2008), the pfna proximal femur nail in treatment of unstable proximal femur fractures, 3 cases of postoperative perforation of the helical blade into the hip joint, journal of orthopedic trauma. Volume 22, pages 731-736 (switzerland). The objective of this study is to report 3 cases of postoperative perforation of the device through the femoral head into the hip joint without any signs of varus collapse due to improper reduction of the fracture. This study presents a case report of an (b)(6) year old female patient who had an unstable pertrochanteric fracture due to a fall. Closed reduction and internal fixation was performed using the long pfna with a 105-mm helical blade. Six weeks later the patient presented again with severe pain after she had fallen onto her left hip for a second time. Follow-up x-rays showed a perforation of the helical blade through the cortex of the femoral head after a shortening of the femoral neck by 2 cm. At her second operation, a replacement of the blade was performed using a shorter 95-mm implant. Postoperatively the patient was again mobilized under full weight bearing, and at 12 weeks follow-up, x-rays showed a healed fracture and the patient was free from pain. This study presents a case report of an (b)(6) year old female patient who presented with an unstable 31-a2 pertrochanteric fracture. Pfna nail with a 105-mm blade was implanted. Nine days later she was admitted to the department of internal medicine because of progressing cardiopulmonary insufficiency. Six-week follow-up x-rays showed a perforation of the blade through the medial femoral head into the femoral cartilage. A reoperation with a 95-mm helical blade was inserted. Postoperatively full weight bearing occurred. Six weeks later the patient presented free from pain. Follow-up x-rays revealed a healed fracture. This study presents a case report of a (b)(6) year old female patient who sustained an unstable 31-a2 fracture of the proximal femur. A pfna with a 100-mm helical blade was inserted. Six weeks postoperatively she presented with slight pain in the right hip. Mobilization under full weight bearing was possible but the patient complained of limited range of movement. X-rays showed perforation of the blade into the acetabulum. The nail was removed, and an uncemented total hip replacement was performed. Intraoperatively, a microbiological smear was taken showing growth of haemophilus and streptococcus species. Antibiotic therapy with amoxicillin was started. At 6 weeks after arthroplasty the patient was free from pain and showed no signs of infection, and the antibiotic was discontinued. This report is for an unknown synthes pfna helical blade. It captures the reported (b)(6)year old female patient who had a perforation of the helical blade through the cortex of the femoral head which was replaced. This is report 1 of 3 for (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: PFNA BLADE
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12343507
MDR Text Key268312762
Report Number8030965-2021-06895
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
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 Received10/04/2021
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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