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

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

Patient Problems Ambulation Difficulties (2544); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nails: 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.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: rodriguez, n.Et al.(2019), standardized cement augmentation in extracapsular hip fractures: is a safe and reproducible technique to increase anchorage in osteoporotic bone?, osteoporosis international, vol.30(2), page 786 (spain).The objective of this study is to evaluate safety, complications and functional result of extracapsular hip osteoporotic fractures treated with standardized cement augmentation with the pfna-augmentation nail.Between 2010 to 2017, a total of 81 patients (65 females and 16 males) with a mean age of 85.88 years who had unstable fractures underwent standardized cement augmentation with the pfna-augmentation nail.Mean follow-up was 14.5 months (12-24 months).The following complications were reported as follows: 15 patients died during follow-up for reasons unrelated to the surgical technique 7 patients had poor fracture reduction.17 patients could not walk again.4 cases had mechanical complications.1 patient had peri-implant fracture that needed surgical revision.3 cases had "back-out".This report is for an unknown synthes pfna - augmentation nail.This report is for one (1) unk - nails: pfna.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - NAILS: PFNA
• 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: 11436227
• MDR Text Key: 239765136
• Report Number: 8030965-2021-01667
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• 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: 02/10/2021
• 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