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

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

Patient Problems Arthritis (1723); Muscular Rigidity (1968); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: plate/screws/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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: tyllianakis, m., solou, k., lakoumentas, j., and panagopoulos, a.Et al.(2022), long-term functional outcomes and complications of intra-articular (ao type b, c) distal humerus fractures in adults: a retrospective review, cureus, vol.14(1): e21094, pages 1-9 (greece).The purpose of this study was to retrospectively review the long-term functional outcome and complications of all available patients with intra-articular distal humerus fractures, treated surgically in our university hospital in the last 25 years.Twenty-five patients were re-examined clinically and radiographically between january 2020 and march 2021, at a mean of 158.16±73.73 (48-305) months after the initial treatment.Open reduction and internal fixation were performed at an average of 2.4 days (1-6 days) after the injury.Open reduction and internal fixation (orif) were achieved with headless screws, k-wires, or plates (3.5mm dcp, 3.5mm lcp, one-third tubular plates, or 3.5mm pelvic reconstruction plates, at 90° or 0°).Double plating was used in 11 cases.The average follow-up was 158.16 ± 73.73 months.The article does not identify which specific depuy synthes product (dcp or lcp) is associated with the adverse event(s).12 patients died.Patient 4: a 72-year-old female patient had posttraumatic arthritis grade 1.Patient 5: a 71-year-old female patient had posttraumatic arthritis grade 3.Patient 6: a 62-year-old female patient had posttraumatic arthritis grade 3.Patient 7: a 60-year-old female patient had posttraumatic arthritis grade 2, pain and stiffness.She also had a reoperation.Patient 9: a 50-year-old male patient had posttraumatic arthritis grade 1, pain and stiffness.He also had a reoperation.Patient 10: a 80-year-old female patient had pain and stiffness.She also had a reoperation.Patient 11: a 96-year-old male patient had posttraumatic arthritis grade 2.Patient 14: a 53-year-old male patient had posttraumatic arthritis grade 3, pain and stiffness.He also had a reoperation.Patient 16: a 27-year-old male patient had posttraumatic arthritis grade 2 and deep infection.He also had a reoperation.Patient 18: a 18-year-old male patient had posttraumatic arthritis grade 2 and superficial infection.Patient 21: a 18-year-old male patient had posttraumatic arthritis grade 4, pain and stiffness.He also had a reoperation.Patient 23: a 74-year-old female patient had posttraumatic arthritis grade 2, stiffness (heterotropic ossification).She also had a reoperation.Patient 24: a 33-year-old female patient had an ulnar palsy that was resolved.Patient 25: a 52-year-old female patient had posttraumatic arthritis grade 2, hardware failure, resolved radial and ulnar nerve palsies.She also had 3 reoperation.This report is for unknown synthes 3.5mm lcp and 3.5mm dcp.This is report 1 of 8 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 14855645
• MDR Text Key: 295066704
• Report Number: 8030965-2022-04476
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• 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