MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: PFNA; ROD, FIXATION, INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: 510k: this report is for an unknown pfna nail/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.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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:halonen, l.M., stenroos, a., vasara, h., and kosola, j.(2021), peri-implant fracture: a rare complication after intramedullary fixation of trochanteric femoral fracture, archives of orthopaedic and trauma surgery, vol.Xx, pages 1-6 (finland).The aim of the study was to describe the incidence of a peri-implant fracture (pif), compare the risk with short and long cephalomedullary nails, and describe the treatment and the treatment results of pif.The study was a single-center retrospective analysis of 987 consecutive trochanteric fractures on 966 patients (ao/ota 31-a), all treated with intramedullary nailing with proximal femoral nail antirotation (pfna) intramedullary nail (depuy synthes, raynham, massachusetts, us).A short nail (200 mm) was used in 74 patients, intermediate-length nail (240 mm) 728 patients, and a long nail (300¿420 mm) in 150 patients.For 35 patients, nail length was not defined in the charts, but could be deduced to be 200 mm or 240 mm.The patients were operated on in the years 2011¿2016 and the followup from the patient records was for a minimum of 2 years after the operation or until death.The following complications were reported as follows: 349 patient who didn't develop pif died at 2 years.Patient 1: an 87-year-old was treated with a long nail.The patient developed pif (distal tip of im nail) the nail was removed and revised with a plate.Patient 2: an 82-year-old patient was treated with an intermediate- length nail.The patient developed pif (distal tip of im nail).The nail was removed and revised with a plate.Patient 3: a 90-year-old patient was treated with a short nail.The patient developed pif (by the im nail).The patient was treated with exchange nailing.Patient 4: an 89-year-old patient was treated with an intermediate- length nail.The patient developed pif (distal tip of im nail).The patient was treated with exchange nailing patient 5: a 96-year-old patient was treated with an intermediate- length nail.The patient developed pif (distal tip of im nail).The patient was treated with exchange nailing.The patient died at 2 years after pif.Patient 6: a 75-year-old patient was treated with an intermediate- length nail.The patient developed pif (by the im nail).The patient was treated with exchange nailing.Patient 7: a 92-year-old patient was treated with an intermediate- length nail.The patient developed pif (distal tip of im nail).The nail was removed and revised with a plate.The patient died at 2 years after pif.Patient 8: a 93-year-old patient was treated with an intermediate- length nail.The patient developed pif (distal tip of im nail).The nail was removed and revised with a plate.The patient died at 2 years after pif.Patient 9: a 92-year old patient was treated with an intermediate- length nail.The patient developed pif (distal tip of im nail).The patient was treated with exchange nailing.The patient died at 2 years after pif.Patient 10: a 61-year-old patient was treated with an intermediate- length nail.The patient developed pif (distal tip of im nail).The nail was removed and revised with a plate.Patient 11: a 72-year-old patient was treated with a short nail.The patient developed pif (distal tip of im nail).The patient was treated with exchange nailing.Patient 12: a 91-year-old patient was treated with an intermediate- length nail.The patient developed pif (distal tip of im nail).The nail was removed and revised with a plate.The patient died at 2 years after pif.Patient 13: a 105-year-old patient was treated with an intermediate- length nail.The patient developed pif (distal tip of im nail).The nail was removed and revised with a plate.The patient died at 2 years after pif.Patient 14: a 72 -year-old patient was treated with an intermediate- length nail.The patient developed pif (distal tip of im nail).The nail was removed and revised with a plate.This report is for an unknown synthes pfna nail.This report captures the reported 105-year-old patient who was treated with an intermediate- length nail.The patient developed peri-implant fractures (pif) (distal tip of im nail).The nail was removed and revised with a plate.The patient died at 2 years after pif.This is report 13 of 14 for (b)(4).

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: UNK - NAILS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14980557
• MDR Text Key: 295686889
• Report Number: 8030965-2022-04717
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 105 YR