MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 CRTX SCR LOW PROF HD STPING/SD/28; SCREW, FIXATION, BONE

Model Number	02.206.228
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Malunion of Bone (4529)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, patient underwent a removal of variable angle medial tibia plate and corresponding screws due to nonunion.The medial plate was originally put on the lateral side of the patients tibia.Surgeon removed all hardware, created an osteotomy, then put in a zimmer hindfoot nail as well as synthes va proximal tibia plate.Patient consequences were reported.This report is for (1) 2.7 va lckng scr slf-tpng t8 sd rec 36.This is report 10 of 14 for complaint (b)(4).
Additional Manufacturer Narrative
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.
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.H6: investigation summary: the complaint device (3.5 crtx scr low prof hd stping/sd/28) was not received for investigation.A photo investigation was performed based on the photo provided.The image was reviewed, and the complaint condition is not confirmed.After review of the x-ray provided, a plate and screw construct is visible at the lateral aspect of the left tibia with signs of bone fracture in the distal section.The complaint device does not appear to have any defect or malfunction.A manufacturing record evaluation cannot be performed due to lot number being unknown.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.No dhr review was completed since no lot number was supplied via photo or additional information.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.A manufacturing record evaluation cannot be performed due to lot number being unknown.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 CRTX SCR LOW PROF HD STPING/SD/28
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13387794
• Report Number: 2939274-2022-00280
• Device Sequence Number: 16569654
• Product Code: HWC
• UDI-Device Identifier: 10886982051066
• UDI-Public: (01)10886982051066
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K111230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.206.228
• Device Catalogue Number: 02.206.228
• 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: 12/30/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/07/2022
• 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: 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 36; 2.7/3.5 VA-LCP MED DSTL TIBIA PL/16 H/RT; 3.5 CRTX SCR LOW PROF HD STPING/SD/28; 3.5 CRTX SCR LOW PROF HD STPING/SD/28; 3.5 VA LCKNG SCR SLF-TPNG/SD/26; 3.5 VA LCKNG SCR SLF-TPNG/SD/26; 3.5 VA LCKNG SCR SLF-TPNG/SD/26; 3.5 VA LCKNG SCR SLF-TPNG/SD/26
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female