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

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: bonnaire, f., lein, t., fülling, t., and bula, p.(2020), reduced complication rates for unstable trochanteric fractures managed with third-generation nails: gamma 3 nail versus pfna, european journal of trauma and emergency surgery, vol.46 (xx), pages 955¿962 (germany).The aim of this prospective observational and retrospective cohort study is to find out the early (within 6 months) and late complication (up 2.5 years) rate in unstable intertrochanteric fractures stabilized by two different intramedullary cephalocaudal nails in our clinical praxis.Between july 2005 to december 2006, a total of 106 patients were included in the study.Surgery was performed using a proximal femoral nail (pfna) in 53 patients (11 male and 42 female), with an average age of 81 (± 11) years, and a competitor device in 53 patients (16 male and 37 female) with an average age of 83 (± 9) years.Clinical and radiological follow-up assessments were conducted at 6 months after surgery.The mean follow-up period was unknown.The following complications were reported: in 7 patients, reduction in open technique was performed since closed reduction proved difficult.In 15 patients, implant-related intraoperative difficulties were experienced.The three critical factors were: partial reduction loss during nail insertion, implant jamming in the distal medullary cavity because the pfna was too long and persistent intertrochanteric fracture dehiscence.In 2 cases, it was necessary to change to a shorter implant.2 patients had mechanical complications requiring revision.In one patient, there was manifest rotational misalignment that had to be corrected by implant removal and implantation of a total hip replacement.In a second patient, lateralization of the pfna blade was observed and was subsequently replaced with a shorter blade.1 patient had a lateral migration.1 patient suffered renewed trauma to the operated side with severe consequences.The patient fell a second time on the operated side and sustained partial avulsion of the gluteus medius and minimus muscles.This led to the implantation of a total hip replacement.3 patients had superficial wound healing disorders and hematoma requiring revision.15 patients had bladder infection/pneumonia.1 patient had acute coronary syndrome/stroke.20 patients already died after 2.3 years on average.This report is for an unknown synthes pfna constructs, unknown synthes pfna nails, and unknown synthes pfna blade.This report is for (1) unk - constructs: pfna.This is report 2 of 4 (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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11349282
• MDR Text Key: 244213139
• Report Number: 8030965-2021-01166
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2021
• 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