MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: 7.3 MM CANNULATED; SCREW, FIXATION, BONE

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

Patient Problems Necrosis (1971); Non-union Bone Fracture (2369)

Event Date 11/12/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article ren, b.F.Et al (2022) quick and accurate placement of cannulated screws to internal fixation of femoral neck fractures using a novel guide device, advances in therapy, vol.Xx (xx) pages 1-9 (china).The aim of this retrospective study is to compare a novel guide device and conventional technique with regards to the accuracy, operation time, fluoroscopy numbers, and drilling attempts during the insertion of cannulated screws to internal fixation of femoral neck fractures.Between january 2020 to june 2021, a total of 60 patients (range 18 and 60 years old) fulfilled our selection criteria and were included in this study.Patients were divided into 2 groups: (n=30) conventional group (17 female and 13 male with a mean age of 50.2 ± 6.3 years) and (n=30) device-assisted group (20 female and 10 male with a mean age of 49.6 ± 6.0 years).Patients in both groups were fixed by synthes 7.3-mm cannulated nail.In conventional group, a standard parallel guide (synthes 312.71) was used in placing the posterosuperior and anterosuperior pins.The advantage of the guide device-assisted group with regard to the measurements was significant.In the guide-device assisted group, total drilling attempts on the femoral cortex was 5.1 ± 1.2, much lower than in the conventional group (p = 0.000).The patients in the two groups were followed for 12¿24 months.The complications were observed.The following complications were reported as follows: device-assisted group: (n=1) patient who had nonunion.(n=2) patients had osteonecrosis of the femoral head.Conventional group: (n=2) patients who had nonunion.(n=2) patients had head penetration.(n=3) patients had osteonecrosis of the femoral head.This report is for an unknown synthes 7.3-mm cannulated nail.This is report 1 of 1 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

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.510k: this report is for an unknown screws: 7.3 mm cannulated /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.

• Brand Name: UNK - SCREWS: 7.3 MM CANNULATED
• Type of Device: SCREW, 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: 16312726
• MDR Text Key: 308954118
• Report Number: 8030965-2023-01491
• Device Sequence Number: 1
• Product Code: HWC
• 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: 02/07/2023
• 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: 01/13/2023
• 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