MAUDE Adverse Event Report: SYNTHES GMBH TI DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 480.950

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® lag screw 12.7mm thread/95mm this is report 2 of 9 for (b)(4).

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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.D10: therapy date is in (b)(6)2023.H3, h4, h6: part:480.950 lot:4l63312 manufacturing site: werk balsthal supplier:na release to warehouse date: 13 may 2019 expiration date:na a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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® LAG SCREW 12.7MM THREAD/95MM
• Type of Device: APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17415148
• MDR Text Key: 319959046
• Report Number: 8030965-2023-09499
• 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: 480.950
• 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-COMPRSCR L36 TAN; LCP DHS-PL 135° 6HO L124 STANDBARREL TAN; LOCKSCR ø5 SELF-TAP L42 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR