MAUDE Adverse Event Report: SYNTHES GMBH 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 42; PLATE, FIXATION, BONE

Model Number	02.211.042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient underwent revision due to swellling, infection(sepsis), pain and implant failure.Xray and ultrasound confirmed that the hardware in his ankle has failed.The patient is currently taking both oral and iv antibiotics.On (b)(6) 2021 the patient was implanted with synthes devices on left ankle after falling from a tree.This report is for one (1) 2.7 va lckng scr slf-tpng t8 sd rec 42.This is report 4 of 8 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a patient.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: 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 42
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16568882
• Report Number: 8030965-2023-03339
• Device Sequence Number: 12296765
• Product Code: HRS
• UDI-Device Identifier: 10886982053725
• UDI-Public: (01)10886982053725
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• 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: 02.211.042
• Device Catalogue Number: 02.211.042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/17/2023
• 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: 2.7 CORTEX SCREW SLF-TPNG T8 SD REC 40.; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 10.; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 10.; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 10.; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 44.; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 46.; 2.7/3.5 VA ANTEROLAT DSTL TIB PL/6 H/LFT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown