MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 3.5 MM LCP DISTAL HUMERUS PLATE; PLATE,FIXATION,BONE

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

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this report is for an unknown plates: 3.5 mm lcp extra-articular distal humerus plate/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: sur y.J., (2020) results of plate fixation for transcondylar fracture of the distal humerus: a rare pattern of fractures, jses international volume 4, 478-484 (b)(6), south) https://doi.Org/10.1016/j.Jseint.2020.03.008.This retrospective study aims to the results of treatment of orif with anatomic plates in this case series.Between january 2014 and december 2017, patients treated in our hospital for distal humerus fractures were reviewed.A total of 78 patients with distal humerus fractures were identified.Fifty-eight patients with other fracture types, 2 patients with less than 12 months' follow-up, and 1 patient who had undergone total elbow arthroplasty were excluded.Finally, 17 patients with transcondylar fractures who underwent plate fixation and with more than 12 months' follow-up were included in this study.The average age of patients was 73.1 years (range, 41-89), and 3 patients were younger than 65 years.Internal fixation was performed using a 3.5-mm lcp distal humerus plates (depuy synthes,west chester, pa, usa) with an orthogonal pattern in 11 patients and an elbow plate system (acumed, (b)(6), or, usa) with parallel pattern in 6 patients.The average follow-up period was 13.6 months (range, 9-15 months).The following complications were reported as follows: - a case of a (b)(6) female (patient 9) had infected nonunion, the plates were removed and antibiotics-impregnated cement beads were inserted.Four weeks of intravenous antibiotic administration was needed.This patient refused further surgery because of a poor general condition.A case of a (b)(6) male (patient 6) had delayed union.This patient with delayed had a history of cerebral vascular accident.Was instructed to be careful not to fall and to avoid excessive activities.No additional surgery was needed, and bony union was achieved finally.A case of a(b)(6) male (patient 13) had delayed union and screw lossening.This patient with delayed union had a history of cerebral vascular accident.Was instructed to be careful not to fall and to avoid excessive activities.No additional surgery was needed, and bony union was achieved finally.A case of a (b)(6) male (patient 1)had heterotopic ossification (ho), showed ossification at triceps insertion and 30 degrees elbow extension limitation.He had elbow orif 2 weeks after the injury, and the delay in fixation may be the cause of ho.Because he had little discomfort due to the ho, no additional surgery was performed for ho.This report is for an unknown synthes 3.5-mm lcp distal humerus plates.A copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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.

• Brand Name: UNK - PLATES: 3.5 MM LCP DISTAL HUMERUS PLATE
• Type of Device: PLATE,FIXATION,BONE
• 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: 12713179
• MDR Text Key: 284473626
• Report Number: 8030965-2021-09096
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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: 11/03/2021
• 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