MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 VA LCKNG SCR SLF-TPNG/SD/26; PLATE, FIXATION, BONE

Model Number 02.127.126

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: additional product code: hwc.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 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 one (1) 3.5 va lckng scr slf-tpng/sd/26.This is report 4 of 14 for complaint pc-(b)(4).

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: b6 h6: investigation summary: the complaint device (3.5 va lckng scr slf-tpng/sd/26) 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.G2.

• Brand Name: 3.5 VA LCKNG SCR SLF-TPNG/SD/26
• Type of Device: PLATE, 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: 13388661
• MDR Text Key: 287352210
• Report Number: 2939274-2022-00287
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982043177
• UDI-Public: (01)10886982043177
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.127.126
• Device Catalogue Number: 02.127.126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 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 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female