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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown constructs: pfna-ii/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.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

Device report from synthes reports an event in india as follows: this report is being filed after the review of the following journal article: sahu s., pandey a., (2020)short proximal femoral nail a2 vs long proximal femoral nail a2 for the management of intertrochanteric fractures in elderly,european journal of molecular & clinical medicine ,volume 07 (6) , pages 1144-1149 (india).This prospective randomised study aims to correlate functional outcome short pfna2 (antirotation) & long pfna2(antirotation) within the terms of blood loss, surgical time, functional outcome and other modalities.From november 2016 to november 2019, a total of 87 patients with trochanteric fracture were selected and randomly allotted to 2 groups designated to group a 45 patients (short pfna2) (27 males,60 females) with average age of 75yrs (66-84yrs) and group b 42 patients (long pfna2) with (15 males, 27 females) with average age of 77yrs(range: 69-85yrs).Allt he individuals with fracture are checked on 1st, 3rd, 6th & 12th month.The following complications were reported as follows: short pfna: there is some degree of shortening in 2 patients from the short pfn group; 1 femoralcanal impingement, 1 reoperation, 4 limb shortening at 12months, 1 screw cutout,later managed with bipolar hemiarthroplasty.Long pfna: 5 femoral canal impingement causing break in the anterior cortex,the former was managed with a locking plate and the latter with a retrograde im nail.4 reoperation, 1 limb shortening at 12months, 1 patient from the long pfna2 group had a fracture at the distal locking site.2 screw cutout, later managed with bipolar hemiarthroplasty.This report is for an unknown constructs: pfna-ii.This is report 4 of 5 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA-II
• 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: 11392781
• MDR Text Key: 240143263
• Report Number: 8030965-2021-01472
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• 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: 02/05/2021
• 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