MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PFNA SHORT; 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

Product complaint #: (b)(4).This report is for an unk - constructs: pfna/unknown lot.Part and lot numbers are unknown; udi 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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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

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: yamamoto n., et al (2021) reduction quality and nail fixation ratio as bone-implant stability factors associated with reoperation for trochanteric fractures, injury xxx (xxxx) xxx , pages 1-6 (japan).This retrospective study aims to evaluate the association between bone- implant stability factors, including the imn construct, and post-operative outcomes, especially reoperation, in a more extensive case series and with comprehensive variables.Between january 2008 and june 2020, 390 consecutive patients (306 females, 84 males) with a mean age of 82.9 ¿8.3 years at the time of surgery who underwent imn for an acute trochanteric fracture ao/ota 31a1, a2, and a3 types at a single general hospital in japan were included in the study.During the fixation nails used included proximal femoral nail antirotation (pfna), japanese pfna (depuy synthes, warsaw, in, usa), and other competitors devices.The implant type and size were selected according to the surgeons preference.Patients were followed up at least three months postoperatively.The following complications were reported: 1 reoperation due to non-union (short nail group).1 reoperation due to secondary femoral fracture due to falling (short nail group).1 reoperation due to osteonecrosis (short nail group).1 reoperation due to infection (short nail group).1 reoperation due to iatrogenic surgical error (short nail group).37 intraoperative femoral fracture (short nail group).1 secondary femoral fracture (short nail group).68 complication grades (2 =) (short nail group).1 reoperation due to nonunion (long nail group).8 intraoperative femoral fracture (long nail group).18 complication grades (2 =) (long nail group).Blood loss volume, cc (sd) 255.80 (208.835) (long nail group).4 re-operation due to cut out (short nail group).1 reoperation due to cut-out (long nail group).1 reoperation due to blade perforation (short nail group).1 reoperation due to implant breakage (short nail group).This report is for an unknown synthes proximal femoral nail antirotation (pfna) and japanese pfna.This report is for (1) unk - constructs: pfna.This report is 5 of 12 for (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.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.

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.H10 additional narrative: 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 SHORT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12169824
• MDR Text Key: 267732275
• Report Number: 8030965-2021-05744
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention