MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 60MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	212.221
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2020
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.Date of event: only the event month and year are known.Procodes: hrs, hwc.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The initial reporter is a j&j 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.
Event or Problem Description
It was reported that on or about (b)(6) 2019, patient suffered fall and was implanted with 4.5 mm proximal tibial plate and synthes screws.On or about (b)(6) 2020, patient developed infection and was treated and hospitalized.On or about (b)(6) 2020, x-ray was taken of the left lower extremity which revealed acute fracture in the 4.5 mm proximal tibial plate.On or about (b)(6) 2020 patient underwent revision surgery to remove the defective fractured 4.5 mm proximal tibial plate and other associated screws.This pc created to capture the event of patient's infection.This report involves one unk - guide/compression/k-wires.This is report 10 of 10 for (b)(4).This pc is related to the following pcs: (b)(4) - reports additional k-wires.(b)(4) - reports implant breakage.
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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 60MM
• 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: 16417017
• Report Number: 8030965-2023-02113
• Device Sequence Number: 3327599
• Product Code: KTT
• UDI-Device Identifier: 10886982152282
• UDI-Public: (01)10886982152282
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 212.221
• Device Catalogue Number: 212.221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 02/23/2023
• 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: 4.5 LCP PROXIMAL TIB PL 12H/226/LFT-S; 4.5MM CORTEX SCREW SELF-TAPPING 26MM; 4.5MM CORTEX SCREW SELF-TAPPING 28MM; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 26; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 55; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 60; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 60; 5.0MM CANNULATED CONICAL SCREW 80MM; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDE/COMPRESSION/K-WIRES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female