MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: MULTILOC HUMERAL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown.Multiloc proximal humeral nail mphn 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.Lopiz y., et al (2020) third-generation intramedullary nailing for displaced proximal humeral fractures in the elderly: quality of life, clinical results, and complications, archives of orthopaedic and trauma surgery volume, pages 1-12 (spain).This retrospective study aims to analyze the functional results, health-related quality of life (hrqol), and postoperative complications obtained with a straight third generation antegrade nailing of proximal humerus fractures in elderly patients (= 80).Between 2011 and 2018, a total of 32 patients (3 males,29 females) aged 80 y.O.Or older with displaced neer 2-part or 3-part proximal humerus fractures who were treated with a multiloc proximal humeral nail (mphn) (multiloc phn; synthes gmbh, solothurn, switzerland) were included in this study.Of 43 patients aged 80 years or older with an mphn, only 32 patients met the inclusion criteria and were included in the study.The mean follow-up to latest functional assessment was 45.6 months range 16 53 months.The following complications were reported as follows: -of 32 patients included, six had died of a cause unrelated to the surgery at an average of 44.8 26 79.2 months and at an average age at surgery of 84.8 years, all of them with a follow-up superior to the stablished minimum follow up of 12 months.Three poor 40¿0 result according to the irc.Fracture healing was achieved in all but one case, which suffered secondary displacement and needed surgical revision.A total of 6 patients 18.8 underwent second surgeries, like 1 patient was revised to rsa because of a severe secondary fracture displacement.Among those who underwent second surgeries,5 were minor surgeries like hardware removal because of subacromial impingement one case was caused by secondary varus collapse.Four cases of subacromial impingement were due to inadequate technique nail protrusion because height was erroneously assessed during the surgery fig.5 this report is for an unknown synthes multiloc proximal humeral nail (mphn).It captures the four cases of subacromial impingement due to inadequate technique (nail protrusion because height was erroneously assessed during the surgery.This is case 3 of 4.This is report 4 of 5 for (b)(4).

• Brand Name: UNK - NAILS: MULTILOC HUMERAL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 11418030
• MDR Text Key: 249007580
• Report Number: 8030965-2021-01652
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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: 02/12/2021
• 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