MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP; PLATE, FIXATION, BONE

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

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

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.A1, a2, a3, a4: there are multiple patients.All known information is provided in the literature article.D1, d2, d3, d4, g4 - 510k: this report is for an unknown locking compression plate construct/unknown lot.Part and lot number are unknown; udi number is unknown.D6: there are multiple unknown dates of implantation between january 2020 and june 2021.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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: shukur, a.Y.Et al (2022), prospective comparative study between antegrade interlocking undreamed nail versus compression plate fixation of acute closed humeral mid third shaft humerus in adults, rawal medical journal, vol.47 (4), pages 911-916 (iraq).The aim of this prospective randomized comparative cohort study was to compare open reduction compression plate fixation & closed unreamed antegrade interlocking nail in humeral mid-shaft fracture regarding intraoperative loss of blood, union time, operative time, nerve injury, duration of hospitalization, functional outcomes, postoperative complications.Between january 2020 and june 2021, a total of 30 patients (20 male and 10 female) with a mean age of 41.10 ± 14.21 years (range 19 ¿ 64) were included in the study.They were randomly divided into 2 groups: group a involves those who were treated by imn (unknown manufacturer), and group b involves those who were treated by lcp.Patients follow up was done at 2 weeks, 3 months, and 6 months¿ intervals, in terms of clinical and radiological union (bony bridging at three cortices out of four cortices).The functional outcome was assessed by using quick dash score at six-month post-op.The following complications were reported: 2 patients developed iatrogenic transient radial nerve injury.A wrist drop brace with continuous physiotherapy was applied.Fortunately, the radial nerve palsy healed within 3 months in all patients.2 patients developed a superficial infection.1 patient developed deep infection.2 patients developed non-union.1 patient had delayed union.This report is for an unknown synthes lcp.A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - CONSTRUCTS: LCP
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18907509
• MDR Text Key: 337729707
• Report Number: 8030965-2024-03676
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 02/27/2024
• 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