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 Non-union Bone Fracture (2369); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna constructs/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: kristan, a., benulic, c., and jaklic, m.(2021), reduction of trochanteric fractures in lateral view is significant predictor for radiological and functional result after six months, injury, vol.Xx (xx), pages 1-6 (slovenia).The primary goal of this retrospective study was to determine most important radiological parameter after the surgery which can predict the position and healing of trochanteric fractures type ao 31 a2 after six months period.The additional goal was to find how the end position of the fracture influences mechanical failure and mobility of the patients.Between january 1, 2016 to december 31, 2016, a total of 92 patients were included in the study.Surgery was performed using sliding hip screw (dhs; depuy synthes) in 13 patients in group a and 19 patients in group b or intramedullary nail for proximal femur (pfna; depuy synthes) for the rest of the patients.If the reduction was recognized as anatomical the position was rated as 0, if nsa was in valgus or mca or acs were positive (proximal fragment was medial to the shaft for mcs or anterior to the shaft for acs) the rate was 1 and if the nsa was in varus or mcs or acs were negative (proximal fragment was lateral to the shaft for mcs and posterior to the shaft for acs) it was rated as 2.Groups were divided according to the position of proximal fragment after six months.In group a (46 patients; 12 male and 34 female; mean age = 78 ±13 years) the patients had all tested reduction parameters (nsa, mcs, acs) below 2 after six months, so the overall position was recognized as satisfactory.In group b (46 patients; 12 male and 34 female; mean age = 80 ±8 years) patients had at least one parameter rated as 2 six months after the surgery and the position of the proximal fragment was considered as unsatisfactory.The mean follow-up period was unknown.The following complications were reported as follows: group a: 3 patients had fixation failure: reduction lost (n=2) and excessive sliding (n=1).Group b: 5 patients had nonunion.In 46 patients, the position of the proximal fragment was considered as unsatisfactory and were noticed to have a shifting of all three position towards unsatisfactory (score 2).In the parker index in anterior projection, 1 patient had superior position of the implant and all others had inferior position of the implant.In the parker index in lateral projection, 2 patients had anterior position and all others had inferior position of the implant.An unknown number of patients with negative fragment positions in acs after the surgery tended to have worse fracture position after six months.25 patients had fixation failure: cut-out (n=4), reduction lost (n=6), and excessive sliding (n=15).This report is for an unknown synthes pfna constructs.It captures the reported event of fixation failure: reduction lost and nonunion.This is report 4 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: 12080493
• MDR Text Key: 268067298
• Report Number: 8030965-2021-05381
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SI
• 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
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 06/28/2021
• 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