MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0 PERIPRO VAL SCR SLF-TPNG/SD/12; CONDYLAR PLATE FIXATION IMPLANT

Model Number	02.231.012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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.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 after the surgery during the removal of valcp curved condylar plate, screws, and a zimmer retrograde nail due to infection and nonunion.Patient¿s previous below knee amputation was revised to an above knee amputation.The patient experienced no post-op device malfunction.This complaint involves twelve (12) devices.
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: h3, h6: a photo investigation was completed: the depuy synthes team conducted a visual inspection of the provided x-ray photos.There is no malfunction reported, however a visual analysis of the x-ray photo provided by the customer was performed and it was observed that there are no anomalies with the device.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed.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: 5.0 PERIPRO VAL SCR SLF-TPNG/SD/12
• Common Device Name: CONDYLAR PLATE FIXATION IMPLANT
• 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 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13839735
• Report Number: 2939274-2022-00986
• Device Sequence Number: 836319
• Product Code: JDP
• UDI-Device Identifier: 10886982061836
• UDI-Public: (01)10886982061836
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.231.012
• Device Catalogue Number: 02.231.012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/14/2022
• 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 VACRVD CONDY PL/12H/266/RT; 5.0 PERIPRO VAL SCR SLF-TPNG/SD/12; 5.0 PERIPRO VAL SCR SLF-TPNG/SD/12; 5.0 PERIPRO VAL SCR SLF-TPNG/SD/12; 5.0 PERIPRO VAL SCR SLF-TPNG/SD/12; 5.0 VA LOCKNG SCR SLF-TPNG/SD/60; 5.0 VA LOCKNG SCR SLF-TPNG/SD/60; 5.0 VA LOCKNG SCR SLF-TPNG/SD/60; 5.0 VA LOCKNG SCR SLF-TPNG/SD/60; 5.0 VA LOCKNG SCR SLF-TPNG/SD/60; 5.0 VA LOCKNG SCR SLF-TPNG/SD/60; 5.0 VA LOCKNG SCR SLF-TPNG/SD/60
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female