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

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

Patient Problems Pain (1994); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown humeral nail/ unknown lot.Part and lot number 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.(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: mucciolia c., et al (2020) rotator cuff integrity and shoulder function after intra-medullary humerus nailing, orthopaedics & traumatology: surgery & research, volume 106, pages 17¿23, (france).This retrospective study aims to assess rotator cuff integrity and shoulder function after 3rd-generation imn in humeral fracture.Between november 2016 and july 2017, a total of 40 out of 50 eligible patients (26 females and 14 males) mean age at trauma, 60 years (range, 20-89 years) with displaced proximal humeral or humeral shaft fractures treated by 3rd generation imn were included in the study.Two types of 3rd generation im nail were used: multiloctm (depuy-synthes, west chester, pa, usa), and aequalistm (wright-tornier, bloomington, mn, usa).34 patients were treated with aequalis (tornier¿wright) and 6 with multiloc (depuy¿synthes).Patients were followed in clinics at 6 months for clinical, radiological and ultrasound examination.The following complications were reported: two shaft fractures were unhealed at 6 months, 1 of which underwent revision at 10 months for decortication, bone graft and screwed plate fixation.One case of painful lhb, tendinopathy was treated by arthroscopic tenotomy without nail removal.2 cases of shaft non-union.1 case of ascended greater tuberosity malunion.6 cases of persistent varus: 3 due to insufficient reduction (99 degrees varus preoperatively and 112 degrees postoperatively).6 cases of persistent varus: and 3 due to secondary displacement with medial comminution and excessively lateral nail entry.Nail entry portal was being lateral (tuberosity-cartilage junction) in 19 cases.Nail entry portal was being too lateral (tuberosity) in 6.Nail height was low in 5 cases.Results ultrasound found 5 supraspinatus tendon tears: 2 full and 3 deep partial tears.In 2 of the 3 deep partial tears, the nail was protruding and lateral (tuberosity-cartilage junction).Nail height was protruding in 3 cases.One excessively long lateromedial proximal screw in a multiloc nail, causing impingement with the glenoid, was removed.Eight patients (7 with proximal humerus fracture) showed lhb tenosynovitis, defined as abnormal quantity of liquid in the groove on ultrasound.Ct demonstrated technical issues in 4 of the 8 patients: 3 cases of lhb tenodesis by anterior screw and 1 of lhb impingement by an excessively long posterior screw.There were 5 deaths.This report is for an unknown synthes multiloctm intramedullary nail.This is report 1 of 6 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: HUMERAL NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9981453
• MDR Text Key: 196625393
• Report Number: 8030965-2020-02966
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• 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: 04/07/2020
• 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