MAUDE Adverse Event Report: SYNTHES GMBH TI DHS®/DCS® COMPRESSION SCREW 36MM; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 480.990

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Device report from synthes reports an event in italy as follows: it was reported that a patient underwent surgery to implant the plate and screws in (b)(6) 2021.On an unknown date, the devices were explanted due to infection.This report is for a ti dhs®/dcs® compression screw 36mm.This is report 4 of 9 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date is in (b)(6) 2023.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: TI DHS®/DCS® COMPRESSION SCREW 36MM
• Type of Device: APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17415715
• MDR Text Key: 320032076
• Report Number: 8030965-2023-09508
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K953607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 480.990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/28/2023
• 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
• Treatment: CORTSCR Ø4.5 SELF-TAP L42 TI; CORTSCR Ø4.5 SELF-TAP L42 TI; CORTSCR Ø4.5 SELF-TAP L44 TI; CORTSCR Ø4.5 SELF-TAP L44 TI; CORTSCR Ø4.5 SELF-TAP L44 TI; DHS/DCS-SCR L95 TAN; LCP DHS-PL 135° 6HO L124 STANDBARREL TAN; LOCKSCR ø5 SELF-TAP L42 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR