MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI CANNULATED LOCKING SCREW 25MM; PLATE, FIXATION, BONE

Model Number	04.205.025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional 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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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 history lot: part # 04.205.025s, lot # 9l29987, manufacturing site: werk selzach, release to warehouse date: 27.Apr.2022, expiration date: 01.Apr.2032, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 04.205.025, non-sterile lot # 684p200, manufacturing site: werk selzach, supplier : (b)(4), release to warehouse date: 07.Mar.2022.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 or Problem Description
Device report from depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, after surgery the infection was found, and the patient was started on antibiotics.The patient underwent an orif surgery for plateau fracture of proximal left tibia on (b)(6) 2023.Procedure was completed successfully without any surgical delay.Infection was seen on the lateral and medial sides of the proximal tibia.The patient will be monitored with antibiotics to prioritize bone-union.No further information is available.This report is for one (1) 5.0mm ti cannulated locking screw 25mm.This is report 4 of 12 for complaint (b)(4).

• Brand Name: 5.0MM TI CANNULATED LOCKING SCREW 25MM
• Common Device Name: PLATE, FIXATION, BONE
• 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 ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 17169631
• Report Number: 8030965-2023-07722
• Device Sequence Number: 7201113
• Product Code: HRS
• UDI-Device Identifier: 10886982116314
• UDI-Public: (01)10886982116314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Operator of Device: Health Professional
• Device Model Number: 04.205.025
• Device Catalogue Number: 04.205.025S
• Device Lot Number: 9L29987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANN-LOCKSCR ø5 L25 TAN; CANN-LOCKSCR ø5 L80 TAN; CANN-LOCKSCR ø5 L80 TAN; CANN-LOCKSCR ø5 L80 TAN; CORTSCR Ø4.5 SELF-TAP L32 TI; CORTSCR Ø4.5 SELF-TAP L46 TI; LCP PROXIMAL TIBIAL PL 4.5/5 LAT LE SHAF; LCP-T-PL-4.5/5 SHAFT 4HO L83 TI; LOCKSCR Ø5 SELF-TAP L32 TAN; LOCKSCR Ø5 SELF-TAP L34 TAN; LOCKSCR Ø5 SELF-TAP L34 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female