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

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

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Post Traumatic Wound Infection (2447); Unspecified Tissue Injury (4559)

Event Date 07/15/2009

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna construct/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: penzkofer, j., mendel, t., bauer, c., and brehme, k.(2009), treatment results of pertrochanteric and subtrochanteric femoral fractures: a retrospective comparison of pfn and pfna, unfallchirurg, vol.112 (xx), pages 699¿705 (germany).The aim of this retrospective study is to study the question whether the use of the pfna in the clinical field will yield better results as well as a reduction of the surgery-related complications compared to the pfn.Between april 2005 to september 2006, a total of 65 patients (19 male and 46 female) with a median age of 75 years were followed up on, who were treated with a pfn.After switching to the successor model pfna in september 2006, another series of 66 patients (17 male and 49 female) with a median age of 77 ± 12.8 years were followed up on december 2007.A total of 55 (84.6%) patients could be included in the follow-up in the pfn group and 60 patients (90.9%) in the pfna group.The mean follow-up time was 7 months in each group.The following complications were reported as follows: pfn group: 10 study patients had already passed away by the time of their exam or could not be reached.4 patients suffered fissures/fractures on the proximal femur in the course of the surgery.19 patients had mechanical and/or soft tissue related complications that needed revision.1 patient had periimplantary shaft fracture.2 patients had pseudoarthrosis.2 patient had infection/wound healing difficulties.In 2 patients, a re-osteosynthesis became necessary, 7 x (10.8%), a secondary endoprosthetic treatment was required.With 1 patient, the primarily performed pfn osteosynthesis ended in a girdlestone situation.6 patients had implant or osteoporosis related revision surgeries of a "cutting out" (9.2%), 3 times associated with a z effect (4.6%).In 3 cases (4.6%) an early lateral migration of the femur neck components of the pfn resulted in the need for a surgical revision.Pfna group: 2 patients suffered fissures/fractures on the proximal femur in the course of the surgery.11 patients had mechanically related complications that needed revision.2 patient had soft tissue related complications that needed revision.5 patients had infection/wound healing difficulties.1 patient had hematoma.In 1 patient, a re-osteosynthesis was necessary.5 patients resulted in a hip prosthesis.3 patients had a cut-out of the blade (4.5%).In 1 patient, the blade had to be removed prematurely because of a pending cut-out.A (b)(6) year old female patient had a cranial migration of the pfna blade with transacebular perforation into the small pelvis.This report is for an unknown synthes pfna constructs.It captures the following adverse events: suffered fissures/fractures on the proximal femur; mechanically related complications that needed revision, soft tissue related complications that needed revision, infection/wound healing difficulties, hematoma, and underwent re-osteosynthesis resulted in a hip prosthesis.This is report 3 of 6 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• 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: 10904935
• MDR Text Key: 218931700
• Report Number: 8030965-2020-09210
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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: 10/30/2020
• 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