MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/50MM; CONDYLAR PLATE FIXATION IMPLANT

Model Number 02.231.250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/22/2020

Event Type  Injury  

Event 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: on (b)(6) 2019; doe: on (b)(6) 2020; left femur.This report is for a 5.0mm variable angle lockng screw/slf-tpng/strdrv/50mm.This is report 4 of 14 for (b)(4).

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 procodes: hrs, hwc.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical product: date of concomitant therapy is (b)(6) 2019.Initial reporter is a synthes employee.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: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/50MM
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• 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: 16724069
• MDR Text Key: 313153742
• Report Number: 8030965-2023-04470
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982062178
• UDI-Public: (01)10886982062178
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.231.250
• Device Catalogue Number: 02.231.250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 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 68MM.; 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.; 5.0MM 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.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female