MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: HUMERAL NAIL; NAIL,FIXATION,BONE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Necrosis (1971); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.510k: this report is for an unknown humeral nail construct/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between february 2011 to march 2016.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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: kloub, m.Et al.(2019), intramedullary nailing of displaced four-part fractures of the proximal humerus, injury, vol.50, pages 1978-1985 (czech republic).The aim of the prospective study was to evaluate clinical results of intramedullary nailing of displaced four-part fractures and analyse influence of the reduction quality on the functional outcome.Our hypothesis was that better reduction will lead to better functional outcome.From february 2011 to march 2016, a total of 35 patients (20 females and 15 males) with an average age of 62.3 years (sd, 127; range,35¿81) were treated with an orif surgery using an intramedullary nail multiloc phn (depuy synthes, usa).The follow-up was a minimum of 12 months.The following complications were reported as follows: 1 patient died.An (b)(6) year-old female patient had a complete avascular necrosis.A (b)(6) year-old female patient had loss of reduction and infection.She was revised with an atb spacer and an rtsa.A (b)(6) year-old male patient had a complete avascular necrosis.He was revised with a hemiarthroplasty.A (b)(6) year-old male patient had resorption of greater tuberosity.He had a secondary surgery of arthroscopy and removal.A (b)(6) year-old male patient had a partial avascular necrosis.A (b)(6) year-old female patient had a complete avascular necrosis.She had metal removal.A (b)(6) year-old male patient had resorption of greater tuberosity.He had metal removal.An (b)(6) year-old female patient had a partial avascular necrosis.A (b)(6) year-old male patient had loss of reduction.A (b)(6) year-old male patient had a complete avascular necrosis.He was revised with rtsa.A (b)(6) year-old female patient had resorption of greater tuberosity.She was revised with rtsa.A (b)(6) year-old male patient had a partial avascular necrosis.A (b)(6) year-old male patient had a complete avascular necrosis.He was revised with a hemiarthroplasty.A (b)(6) year-old female patient had loss of reduction.A (b)(6) year-old female patient had a complete avascular necrosis.She had metal removal.A (b)(6) year-old female patient had loss of reduction.A (b)(6) year-old female patient had migration of the head proximally.She was revised with rtsa.A (b)(6) year-old female patient had resorption of greater tuberosity.A (b)(6) year-old female patient had nail protrusion proximally.She had metal removal.10 patients had moderate reduction and 3 patients had poor reduction.This report is for an intramedullary nail multiloc phn (depuy synthes, usa).This report is for one (1) humeral nail construct.This is report 3 of 9 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: HUMERAL NAIL
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10002388
• MDR Text Key: 196672964
• Report Number: 8030965-2020-03132
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• 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: 04/08/2020
• 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
• Patient Age: 64 YR