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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna nail/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: cordero-ampuero j., peix c., marcos s., cordero g-g e., (2021) influence of surgical quality (according to postoperative radiography) on mortality, complications and recovery of walking ability in 1425 hip fracture patients, injury xxx (xxxx) xxx, pages 1-5 (spain).This retrospective observational study aims to analyze the influence of surgical quality (as evaluated in the postoperative radiographic control) on mortality, complications and walking ability in patients older than 65 years with a hip fracture.From december 16th 2012 to march 31st 2018, 1425 patients with average age of 85.66 ±7.13 (65-108) years and 966 were female diagnosed of acute hip fracture treated surgically in a single-center, university general hospital attending the center of a big european city were included in the study.Extracapsular fractures (ota 31a2, 31a3 and 31b3) were treated in 795 patients with a trochanteric nail (affixus, biomet trauma, varsaw, indiana, usa, or pfna, synthes gmbh, ch) and in 16 with a sliding hip-screw (hiploc, biomet, south wales, uk).Intracapsular fractures were treated with competitor¿s devices.Patients were followed-up in our outpatient clinics for a minimum of 12 months.The following complications were reported as follows: after the hip fracture, 196 operated patients died along the first year.Among those of them treated with a trochanteric nail, 110 passed away.A poor fracture reduction was statistically significant for mortality (p = 0.0495) with a relative risk of 1.510 (1.01-2.26).Seventy-four patients treated with an arthroplasty died along the first year.It is of interest that a varus position of the stem is almost statistically related to mortality (p = 0.056), with a relative risk of 1.56 (1.00- 2.43).When considering the patients receiving cannulated screws, 12 died along the first year (8.42%).A loss of reduction was again a significant factor for mortality (p = 0.0023), with a significant relative risk of 6.48 (2.40-17.53).A poor reduction could be observed in 147 cases, a tip-apex distance greater than 25mm in 145, and insufficient fracture compression in 114.Among trochanteric nails, 18 suffered surgical wound infection.8 nonunion.A ¿cut-out¿ type of fixation failure was observed in 11 trochanteric nails.A tip-apex distance over 25mm was significantly related to "cut-out" complication (p = 0.041), with a relative risk of 4.47.A breakage of the trochanteric nail developed in 7 cases.Poor reduction was a significant risk factor (p = 0.041) for nail breakage, with a relative risk of 4.47 this report is for an unknown synthes pfna.Nail.This report captures the reported poor reduction, a tip-apex distance greater than 25mm in 145, and insufficient fracture compression in 114, surgical wound infection and nonunion.This is report 1 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12343207
• MDR Text Key: 267300192
• Report Number: 8030965-2021-06877
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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: 10/18/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention