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); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: kruse m., et al (2021) peri-implant femoral fractures in hip fracture patients treated with osteosynthesis: a retrospective cohort study of 1965 patients, european journal of trauma and emergency surgery volume xxxx, pages 1-6 (sweden).This retrospective cohort study aims to investigate the incidence of postoperative peri-implant femoral fractures (piff) following osteosynthesis of proximal femoral fractures.Between 2003 and 2015, 1965 patients (685 males, 1280 females) mean age 80 years [range 50¿102]) with trochanteric hip fractures with osteosynthesis were included.Of these, 382 ( were treated with a cmn, 933 with shd and 650 with pins for femoral neck fractures.The following devices were used either a long or short cmn (gamma3® (stryker, kalamazoo, mi, usa), pfn/pfna (depuy synthes®)), shd (dynamic hip screw (dhs, depuy synthes®) or hansson twin-hook (swemac orthopaedics ab, linköping, sweden)) based on surgeons´ preference.Femoral neck fractures (fnf) were treated with pins (hansson hook pin system (swemac orthopaedics ab, linköping, sweden).Patients were followed-up until removal or for a mean of 4 years (range 0¿15) replacement of osteosynthesis, death or december 2018.The following complications were reported as follows: the 1-year mortality in the entire cohort was 23%.The 1-year mortality rate after piff was 34%.A total of 41 piffs were identified at a mean time of 27 months (range 0¿143 months) postoperatively.In total 27 of 41 patients underwent surgery for piff and 4 (4/27) needed revision surgery.The cumulative incidence of piff was 0.8% for cmn, 2.7% for shd (hr 2.9, 95% ci 0.87¿9.6, p = 0.08) and 2.0% (hr 2.3, 95% ci 0.6¿8.1, p = 0.2) for pins using the cmn as the denominator.Among cmn, 2 piffs occurred with short cmn (n = 250) and 1 piff with a long cmn (n = 132) 1 posttraumatic osteoarthritis-arthroplasty.1 wound rupture.1 cmn: cut-out reosteosynthesis.This report is for an unknown synthes pfn/pfna nail.This is report 2 of 5 for (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: 12343090
• MDR Text Key: 267435668
• Report Number: 8030965-2021-06866
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2021
• 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