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

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown multiloc humeral nail constructs/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: mocini f, et al.(2021), newer generation straight humeral nails allow faster bone healing and better functional outcome at mid-term, j orthop surg res, volume 16, number 631, pages 1-7, https://doi.Org/10.1186/s13018-021-02776-w (italy).The purpose of this retrospective study was to compare clinical and radiographic outcomes in patients who had undergone antegrade intramedullary nail fixation for proximal humerus and humeral diaphysis fractures using different nail designs.Between january 2013 and july 2018, 243 patients with simple or complex fracture in the proximal or diaphyseal region of the humerus who had undergone surgery for antegrade intramedullary humeral nailing were included in the study.The patients were divided into 2 groups according to the design of the imn used: straight nail group (unknown synthes multiloc humeral nails) and curved nail group (unknown synthes solid humeral nail uhn).The straight nail group consisted of 128 patients with 57 males and 71 females with a mean age of 59 +/-19 years (range 18-97).The curved nail group consisted of 115 patients with 56 males and 59 females with a mean age of 53 +/-16 years (range 18-88).Postoperatively, the patients were to remain with a simple sling on the operated side.After 2 weeks from the surgery, the patient was encouraged to stimulate passive range of motion exercises, according to pain sensitivity.After 4 weeks from the surgery, activities of strengthening and elongation of external rotators and scapular stabilizers were initiated.The mean follow-up for the straight nail group was 46+/-9 months (range 24-76).The mean follow-up for the curved nail group was 51+/-8 months (range 24-81).Complications were reported as follows: 5 patients died and were excluded from the study.Straight nail group: 4 patients had nonunion.The fracture was unhealed after 180 days.3 of them were successfully treated with extracorporeal shock wave therapy and/or pulsed electromagnetic fields.1 underwent revision surgery at 8 months with nail removal, bone graft and plate fixation.A complete radiographic bone healing was achieved at final follow up examination.Curved nail group: 3 patients had nonunion.The fracture was unhealed after 180 days.2 of them were successfully treated with extracorporeal shock wave therapy and/or pulsed electromagnetic fields.1 underwent revision surgery at 8 months with nail removal, bone graft and plate fixation.A complete radiographic bone healing was achieved at final follow up examination.This report is for the unknown synthes multiloc humeral nails construct.This report captures the reported event of 4 patients who had nonunion.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: MULTILOC HUMERAL NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 13876988
• MDR Text Key: 292994028
• Report Number: 8030965-2022-01845
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 03/24/2022
• 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