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

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

Pma/510k: 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.Health effect clinical code (b)(4) used to capture code injury.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 89-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 88-year old female patient who presented with an unstable 31-a2 pertrochanteric fracture.Pfna nailwith 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 67-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 an 88-year old female patient who had a perforation of the blade through the medial femoral head into the femoral cartilage.A reoperation with a 95-mm helical blade was inserted.Athis is report 2 of 3 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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.

• Brand Name: UNK - NAIL HEAD ELEMENTS: PFNA BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12343501
• MDR Text Key: 268676580
• Report Number: 8030965-2021-06896
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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 Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR