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); Necrosis (1971); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.510k: this report is for an unknown pfna construct/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between january 1, 2011 to december 31, 2016.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter postal code reported as (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.

Event Description

This report is being filed after the review of the following journal article: halonen, l.M., vasara, h., stenroos, a., and kosola, j.(2020), routine follow-up is unnecessary after intramedullary fixation of trochanteric femoral fractures¿analysis of 995 cases, injury, vol.51, pages 1343-1345 (finland).The aim of this study was to assess the clinical significance of planned visits at outpatient clinic with routine radiographs after intramedullary fixation of trochanteric fractures.From january 1, 2011 to december 31, 2016, a total of 995 consecutives fractures on 973 patients were treated with an intramedullary nail.Implant used were pfna trochanteric nails (depuy synthes).Our follow-up protocol consisted of visits at 6 and 12 weeks after surgery and additional planned follow-up visits according to treating surgeons¿ preference.Skin staples were removed two weeks after the operation.Patients were followed from the patient registries for minimum of two years or until death.The following complications were reported as follows: planned outpatient visit: patients had a change in treatment plan at routine follow-ups due to mechanical complications.All these lead to a re-operation as well as the other changes in treatment plan.4 patients had blade cut off, 1 patients had blade migration, 1 patient had locking bolt loosening, 1 patient had a refracture, 2 patients had delayed union.Unplanned outpatient visit: 112 patients solicited an unplanned visit due to emerging problems related to fractures of which 63 patients led to a deviation in treatment plan.Reason for change in treatment plan at emergency department were most likely due to wound infection or refracture due to new fall.14 patients had a refracture, 1 patients had avascular necrosis, 28 patients had infections, 6 patients had pressure sores, 8 patients had blade cut off, 4 patients had blade migration, 3 patients had imn breakage.This report is for an unknown synthes pfna.This report is for one (1) unknown pfna construct.This is report 1 of 10 for (b)(4).This report is linked to (b)(4) and (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: 11332292
• MDR Text Key: 240479474
• Report Number: 8030965-2021-01028
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• 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: 02/03/2021
• 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