MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP PROXIMAL TIBIA PLATE 12H/226MM/LEFT-STERILE; PLATE, FIXATION, BONE

Model Number	240.045S
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
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).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 or about (b)(6) 2019 the patient suffered a fall and was implanted with 4.5 mm proximal tibial plate and synthes screws.On or about (b)(6) 2020 the patient developed an infection and was treated and hospitalized.On or about (b)(6) 2020 an x-ray was taken of the left lower extremity which revealed an acute fracture in the 4.5 mm proximal tibial plate.On or about (b)(6) 2020 the patient underwent a revision surgery to remove the defective fractured 4.5 mm proximal tibial plate and other associated screws.This complaint captures the revision of broken plate and is related to (b)(4).This complaint involves one (1) device.Concomitant devices: 4.5mm cortex screw self-tapping 28mm (part # 214.828 lot # unknown, quantity# 1).4.5mm cortex screw self-tapping 26mm (part # 214.826, lot # unknown, quantity# 1).5.0mm cannulated conical screw 80mm (part # 02.205.280 lot # unknown, quantity# 1).5.0mm locking screw slf-tpng with t25 stardrive recess 60mm (part # 212.221, lot # unknown, quantity# 1).5.0mm locking screw slf-tpng with t25 stardrive recess 55mm (part # 212.220, lot # unknown, quantity# 1).5.0mm locking screw slf-tpng with t25 stardrive recess 26mm (part # 212.207, lot # unknown, quantity# 1).This report is for one (1) 4.5mm lcp proximal tibia plate 12h/226mm/left-sterile.This is report 1 of 1 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.Part # (b)(4).Synthes lot # h305809.Supplier lot # n/a.Release to warehouse date: march 24, 2017.Expiration date: february 28, 2026.Manufacturer: elmira.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
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: a2, b6, b7, e1 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.
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.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.
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.H11 additional narrative: corrected: d4 (primary udi number), e4, h5, h8 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.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 LCP PROXIMAL TIBIA PLATE 12H/226MM/LEFT-STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12003563
• Report Number: 2939274-2021-02971
• Device Sequence Number: 3241997
• Product Code: HRS
• UDI-Device Identifier: 10886982164629
• UDI-Public: (01)10886982164629(10)H305809
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K011978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/21/2021

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 Expiration Date: 02/28/2026
• Device Model Number: 240.045S
• Device Catalogue Number: 240.045S
• Device Lot Number: H305809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 01/24/2023; 10/05/2023; 10/07/2024; 10/25/2024
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/16/2021; 02/08/2023; 10/11/2023; 10/10/2024; 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5 MM CORTEX SCREW SELF-TAPPING 26 MM; 4.5 MM CORTEX SCREW SELF-TAPPING 28 MM; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 26; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 55; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 60; 5.0 MM CANNULATED CONICAL SCREW 80 MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female