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

Catalog Number UNK - SCREWS: 7.3 MM CANNULATE

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

Patient Problem Bone Fracture(s) (1870)

Event Date 11/25/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in israel as follows: this report is being filed after the review of the following journal article: factor, s.Et al (2022), displaced femoral neck fracture in a pregnant patient diagnosed with transient osteoporosis of the hip, sicot-j, vol.8 (44), pages 1-5 (israel).This study presents a case of a 38-year-old female patient who had transient osteoporosis of pregnancy (top) with a displaced sub-capital femur fracture of the left hip.She underwent operative treatment using closed reduction and internal fixation (crif), using three 7.3 mm partially threaded (32 mm), cannulated screws (depuy synthes, johnson & johnson, usa).The lengths of the screws were 80 mm & 85 mm for the upper ones and 90 mm for the inferiors one.The senior author performed the procedure in sixty-four minutes, with no intraoperative complications.After the surgery, she was advised to start her rehabilitation with partial weight-bearing and underwent a single physiotherapy practice during hospitalization.The postoperative radiographic imaging was done one day after the surgery and revealed a collapsed femoral neck, with further displacement.A decision was made to postpone a definitive treatment to a postpartum date.She underwent a cesarean by week 38, with no complications.An x-ray was done as part of the consultation one day after the surgery, showing a consolidation of the fracture.In her most recent follow-up, 24 months following the injury the patient bears weight, with no use of assistive devices.Due to the proximity of the screws to the articular cartilage and in order to assess the bone condition ideally on mri, it was recommended to remove the hardware.This report is for an unknown synthes 7.3 mm cannulated screws.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.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: 16311433
• MDR Text Key: 308933545
• Report Number: 8030965-2023-01460
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - SCREWS: 7.3 MM CANNULATE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• 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
• Patient Age: 38 YR
• Patient Sex: Female