MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM CORTEX SCREW SELF-TAPPING 68MM; SCREW, FIXATION, BONE

Model Number	214.868
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Medical records received.On (b)(6) 2020, an x-ray of femur report and revealed a closed comminuted supracondylar fracture of left femur with nonunion.Doi: (b)(6) 2019; doe: (b)(6) 2020; left femur.This report is for a 4.5mm cortex screw self-tapping 68mm.This is report 10 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: additional procode: ktt complainant part is not expected to be returned for manufacturer review/investigation.Date of concomitant therapy is (b)(6) 2019.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: 4.5MM CORTEX SCREW SELF-TAPPING 68MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK BIO OBERDORF (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 16724074
• Report Number: 8030965-2023-04497
• Device Sequence Number: 7387492
• Product Code: HWC
• UDI-Device Identifier: 10886982154835
• UDI-Public: (01)10886982154835
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,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: 214.868
• Device Catalogue Number: 214.868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/12/2023
• 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 VA-LCP CRVD COND PL/10 HOLE/230/LFT.; 4.5MM CORTEX SCREW SELF-TAPPING 32MM.; 4.5MM CORTEX SCREW SELF-TAPPING 46MM.; 4.5MM CORTEX SCREW SELF-TAPPING 52MM.; 4.5MM CORTEX SCREW SELF-TAPPING 62MM.; 4.5MM CORTEX SCREW SELF-TAPPING 70MM.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/32.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/44.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/50.; 5.0MM CANNULATED VA LOCKING SCREW/85MM.; 5.0MM CANNULATED VA LOCKING SCREW/85MM.; 5.0MM CANNULATED VA LOCKING SCREW/90MM.; 5.0MM CANNULATED VA LOCKING SCREW/90MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female