MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM CANNULATED VA LOCKING SCREW/75MM; SCREW, FIXATION, BONE

Model Number	02.231.675
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional device product codes: hrs, jdp.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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 (b)(6) 2023, there was a hardware removal/revision surgery due to femoral nonunion.From the lateral side, the surgeon removed a va condylar plate and corresponding screws.From the medial side, the surgeon removed a va proximal tibia plate and corresponding screws.The surgeon placed two new plates onto the femur.Three broken screws from the primary surgery were retained in the patient¿s femur.This report involves one 5.0mm cannulated va locking screw/75mm.This report is related to (b)(4), which captures additional implants.This is report 3 of 3 for (b)(4).

• Brand Name: 5.0MM CANNULATED VA LOCKING SCREW/75MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 16896370
• Report Number: 8030965-2023-05946
• Device Sequence Number: 17677160
• Product Code: HWC
• UDI-Device Identifier: 10886982062901
• UDI-Public: (01)10886982062901
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.231.675
• Device Catalogue Number: 02.231.675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/09/2023
• 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: 3.5 VA LCKNG SCR SLF-TPNG/SD/75.; 3.5 VA LCKNG SCR SLF-TPNG/SD/75.; 3.5 VA LCKNG SCR SLF-TPNG/SD/75.; 3.5 VA LCKNG SCR SLF-TPNG/SD/75.; 3.5 VA LCKNG SCR SLF-TPNG/SD/75.; 3.5 VA PROX TIB PL LRG BEND/12H/207/LFT.; 3.5MM CORTEX SCREW SELF-TAPPING 38MM.; 3.5MM CORTEX SCREW SELF-TAPPING 38MM.; 4.5 VA-LCP CRVD COND PL/16 HOLE/336/LFT.; 4.5MM CORTEX SCREW SELF-TAPPING 38MM.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/42.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/42.; 5.0 VA LOCKNG SCR SLF-TPNG/SD/42.; 5.0MM CANNULATED VA LOCKING SCREW/75MM.; 5.0MM CANNULATED VA LOCKING SCREW/75MM.; 5.0MM CANNULATED VA LOCKING SCREW/75MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female