MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 TI VA CRVD COND PL/12 HOLE/266/RT; SCREW, FIXATION, BONE

Model Number	04.124.412
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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: 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) 2022 ,that a hardware removal that took place at hospital - distal femur hardware had broken on a patient.There was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required because patient's distal femur hardware broke, necessitating removal, external fixation, and planned revision surgery.There was patient outcome/consequences.Patient is currently in an external fixation and will need revision of distal femur.This report is for one (1) 4.5 ti va crvd cond pl/12 hole/266/rt this is report 1 of 1 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.H3, h4, h6: part 04.124.412, lot 59p7648: manufacturing site: mezzovico.Release to warehouse date: july 08, 2020.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that the plate was found broken in two parts from the shaft.A dimensional inspection was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The current and manufactured to drawings were reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: 4.5 TI VA CRVD COND PL/12 HOLE/266/RT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15232310
• Report Number: 2939274-2022-03245
• Device Sequence Number: 6292686
• Product Code: HWC
• UDI-Device Identifier: 10886982110961
• UDI-Public: (01)10886982110961
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.124.412
• Device Catalogue Number: 04.124.412
• Device Lot Number: 59P7648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2020
• 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: PHILOS 3.5 5HO SST; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: CORTICAL : TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown