MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 VA PROX TIB PL SMALL BEND/8H/147/LFT; SCREW, FIXATION, BONE

Model Number	02.127.231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.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) 2021, the sales consultant was notified of an add on case.The patient had a complaint to be seen after a tibia plateau fracture and repair due to severe pain and other complications.The original surgery took place on april 2 of 2021 and the patient had a draining fistula at the incision site as well as improper reduction of the original fracture.The surgeon decided to remove all current hardware and verify the presence or the lack of pathogens.Also the patients health needs to be stable before he can proceed with a revision surgery, to properly reduce the joint line and make the limb useable again for the patient.This report is for one (1) 3.5 va prox tib pl small bend/8h/147/lft.This is report 1 of 18 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D4 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.H6 - codes updated to imdrf codes.Investigation summary: the complaint device (3.5 va prox tib pl small bend/8h/147/lft) was not received for investigation.A photo investigation was performed based on the photos attached in notes & attachments section of pc titled ¿ea156286-27fc-4c07-bfa4-94f58201f22c.Jpeg¿ and "14a0d19b-33e4-4151-aeac-2d2f0175d606.Jpeg".The images were reviewed, and the complaint condition is not confirmed.After review of the x-ray provided, a displaced nonunion fracture is visible, the proximal fragments appear to be disassociated from the shaft of the bone.Additionally, a 4.0mm cannulated cancellous screw and washer construct is protruding out of the tibial head.Nevertheless, there are no notable defects identified and no signs of issue with the device(s) shown on the x-ray and no visible causes for pain and infection.The ¿3.5 va prox tib pl small bend/8h/147/lft¿ does not appear to have any defect or deformation.This complaint is not confirmed as a photo inspection does not show malfunction of the complaint device.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - part: 02.127.231-us.Lot: 21p6865.Manufacturing site: (b)(6).Release to warehouse date: 17.Oct.2019.A manufacturing record evaluation was performed for the finished device 02.127.231-us, lot: 21p6865.Non-conformance (b)(4) was identified within labeling step (0130), but without any product impact.(b)(4) was a planned nr (non-product) referenced to cut over activities (temporary disconnection between (b)(6) and (b)(6) which will prevent all synthes sites to follow procedure "se_001023 verpackung synthes europe/synthes usa)".This non-conformance has no impact to the product neither does it not influence any manufacturing irregularities.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: 3.5 VA PROX TIB PL SMALL BEND/8H/147/LFT
• 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 RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12796486
• Report Number: 2939274-2021-06623
• Device Sequence Number: 5111791
• Product Code: HWC
• UDI-Device Identifier: 10886982043566
• UDI-Public: (01)10886982043566
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.127.231
• Device Catalogue Number: 02.127.231
• Device Lot Number: 21P6865
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 10/18/2021; 12/14/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 11/15/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2019
• 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/70; 3.5 VA LCKNG SCR SLF-TPNG/SD/80; 3.5 VA LCKNG SCR SLF-TPNG/SD/80; 3.5 VA LCKNG SCR SLF-TPNG/SD/85; 3.5 VA LCKNG SCR SLF-TPNG/SD/85; 3.5 VA LCKNG SCR SLF-TPNG/SD/85; 3.5 VA LCKNG SCR SLF-TPNG/SD/85; 3.5 VA PROX TIB PL SMALL BEND/8H/147/LFT; 3.5MM CORTEX SCREW SELF-TAPPING 26MM; 3.5MM CORTEX SCREW SELF-TAPPING 28MM; 3.5MM CORTEX SCREW SELF-TAPPING 28MM; 3.5MM CORTEX SCREW SELF-TAPPING 30MM; 3.5MM CORTEX SCREW SELF-TAPPING 30MM; 4.0MM CANNULATED SCREW LONG THREAD/50MM; 4.0MM CANNULATED SCREW-LONG THREAD 56MM; WASHER 7.0MM; WASHER 7.0MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male