MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: 3.5 MM RECONSTRUCTION PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Necrosis (1971); Nerve Damage (1979); Post Operative Wound Infection (2446)

Event Date 02/14/2021

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Pma/ 510k: this report is for an unknown device/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: li, z.Et al.(2021), comparative study of anatomical locking plate and reconstruction plate in treating acetabular fractures, international orthopaedics, vol.45, pages 2727¿2734 (china).The aim of the present study was to compare the outcomes and complications of anatomical locking plate and traditional reconstruction plate in treating acetabular fractures.From january 2009 to january 2016, 83 patients (66 males and 17 females, with an average age of 40.87 ± 14.04 years (range 19 to 73)) were treated with an anatomic locking plate and reconstruction plate.The patients were divided into 2 groups; reconstruction plate group (rpg) and anatomic locking plate group (alpg).Thirty-five patients were treated with the anatomical locking plate, and 48 patients were treated with the reconstruction plate.The rpg used 3.5-mm reconstruction plate and common screws (synthes, switzerland) and the alpg used an anatomic locking plate (weigao orthopaedic materials company, shandong, china).They were followed up for an average of 35 months (range, 25 to 42 months).The following complications were reported as follows: rpg 4 cases had traumatic arthritis, 1 case had osteonecrosis of the femoral head, 2 cases had infection, 2 cases had lower extremity deep vein thrombosis, 1 case of sciatic nerve injury.This report is for an unk - construct: 3.5 mm reconstruction plate/screws.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: 3.5 MM RECONSTRUCTION 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: 15084449
• MDR Text Key: 296390098
• Report Number: 8030965-2022-05083
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/22/2022
• 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: 06/23/2022
• 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): Other