MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LOCKING SCREW SELF-TAPPING 40MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	413.040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from south korea reports an event as follows: it was reported that on an unknown date in (b)(6) 2022, the plate and screws in question were implanted to fix bone and/or ligament joints after trauma caused bone fractures and damage to joint ligaments.At an unknown point after the initial surgery, an infection occurred, so plate removal surgery was performed on (b)(6) 2023.During the revision procedure, it was discovered that a screw head had broken and disconnected from the rest of the screw.This made it difficult to remove the screw, which increased the operation time.The procedure was completed successfully, no further information is provided.This report is for a 3.5mm ti locking screw self-tapping 40mm.This is report 5 of 14 for (b)(4).
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.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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: 3.5MM TI LOCKING SCREW SELF-TAPPING 40MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 16940454
• Report Number: 8030965-2023-06199
• Device Sequence Number: 20634505
• Product Code: KTT
• UDI-Device Identifier: 10886982211866
• UDI-Public: (01)10886982211866
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 413.040
• Device Catalogue Number: 413.040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: LOCKSCR Ø3.5 SELF-TAP L28 TAN; LOCKSCR Ø3.5 SELF-TAP L28 TAN; LOCKSCR Ø3.5 SELF-TAP L30 TAN; LOCKSCR Ø3.5 SELF-TAP L30 TAN; LOCKSCR Ø3.5 SELF-TAP L30 TAN; LOCKSCR Ø3.5 SELF-TAP L35 TAN; LOCKSCR Ø3.5 SELF-TAP L40 TAN; LOCKSCR Ø3.5 SELF-TAP L40 TAN; LOCKSCR Ø3.5 SELF-TAP L45 TAN; LOCKSCR Ø3.5 SELF-TAP L45 TAN; LOCKSCR Ø3.5 SELF-TAP L50 TAN; LOCKSCR Ø3.5 SELF-TAP L50 TAN; UNK - PLATES: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown