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

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: kim, y.V.Et al (2022), impact of coronal plane fragments and anterior big neck fragments on the occurrence of perioperative lateral wall fractures in ao/ota 31-a1,2 intertrochanteric fractures treated with cephalomedullary nailing, european journal of trauma and emergency surgery, vol xx (xx), pages 1-7 (korea, south).The aim of this retrospective study was to find the association between the type of coronal fragments and perioperative lateral wall fractures during treatment of pertrochanteric fractures with cmns.Between september 2016 to december 2020, a total of 463 patients (136 male and 326 female) with a mean age of 80.1 years (31¿100) were included.The cephalomedullary nails used were pfna (pfnaii, synthes, paoli, pa, usa) or gamma nails (stryker, mahwah, nj, usa).Provisional pins, which keep the fracture reduction intact during proximal reaming and nail insertion, were used by the surgeon's discretion.Postoperative radiographs were obtained the day after surgery.Follow up radiographs were taken one week later, two weeks later, one month later, three months later, and so on.Perioperative fracture of the lateral wall was confirmed by the presence of fracture line at the blade entry site on both anteroposterior and lateral radiographs.The following complications were reported as follows: 22 patients had perioperative lateral wall fractures (implant used in 21 were pfna and 1 with a competitor).Patients treated with pfna were as follows: a 90-year-old female patient.An 82-year-old female patient.An 82-year-old male patient.An 83-year-old female patient.A 90-year-old female patient.An 83-year-old male patient.An 89-year-old male patient.A 91-year-old female patient.A 75-year-old female patient.A 77-year-old male patient.A 73-year-old male patient.An 88-year-old female patient.An 87-year-old female patient.An 81-year-old female patient.An 89-year-old female patient.A 100-year-old female patient.An 82-year-old female patient.A 92-year-old male patient.A 79-year-old female patient.A 68-year-old male patient.An 88-year-old female patient.This is report 13 of 20 for (b)(4).This report is for an unknown synthes pfna ii.(77 year old male patient).This complaint is linked to (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.Event date unknown.This report is for an unknown pfna construct/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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.

• Brand Name: UNK - CONSTRUCTS: PFNA-II
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15113614
• MDR Text Key: 296695223
• Report Number: 8030965-2022-05272
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: 06/28/2022
• 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: 77 YR
• Patient Sex: Male