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

Device Problem Migration (4003)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna 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.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: yam, m.Et al (2020), cephalomedullary blade cut-ins: a poorly understood phenomenon, archives of orthopaedic and trauma surgery, vol.140 (xx), pages 1939¿1945 (singapore).The aim of this retrospective multicenter study is to investigate the potential causes of femoral head cut-in with the pfna and propose possible mechanism of this phenomenon.Between october 2011 to february 2018, a total of 1027 patients were included in the study.Surgery was performed using synthes pfna.The mean follow-up period was unknown.The following complications were reported as follows: 3 patients died due to other causes within the one-year follow-up period.23 patients (3 male and 14 female) with a mean age of 78.2 years (range 63¿95 years) had femoral head cut-in or a superomedial migration of the pfna blade into the femoral head and hip joint.Patient 1 had femoral head cut-in.Patient 2 had femoral head cut-in.Patient 3 had femoral head cut-in.Patient 4 had femoral head cut-in.Patient 5 had femoral head cut-in.Patient 6 had femoral head cut-in.Patient 7 had femoral head cut-in.Patient 8 had femoral head cut-in.Patient 9 had femoral head cut-in.Patient 10 had femoral head cut-in.Patient 11 had femoral head cut-in.Patient 12 had femoral head cut-in.Patient 13 had femoral head cut-in.Patient 14 had femoral head cut-in.Patient 15 had femoral head cut-in.Patient 16 had femoral head cut-in.Patient 17 had femoral head cut-in.Patient 18 had femoral head cut-in.Patient 19 had femoral head cut-in.Patient 20 had femoral head cut-in.Patient 21 had femoral head cut-in.Patient 22 had femoral head cut-in.Patient 23 had femoral head cut-in.This report is for an unknown synthes pfna blade.It captures the reported femoral head cut-in in a patient (#8) out of the 23 patients (3 male and 14 female).This is report 8 of 9 for (b)(4).Additional devices are reported under related complaints (b)(4).

• 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
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11417593
• MDR Text Key: 249515489
• Report Number: 8030965-2021-01647
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2021
• 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