MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/14 HOLES/RIGHT; PLATE,FIXATION,BONE

Model Number	02.118.012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, patient underwent a hardware removal and revision orif tibia procedure.It was noted that preoperative x-rays reveal bent or broken 2.7/3.5mm medial distal tibia plate, 14 hole, right.Patient is insensate neuropathic, diabetic.Patient is unaware of how plate was bent or broken.It is unknown if the procedure was successfully completed.There was a patient consequence reported.Concomitant devices reported: unk - screws: trauma(part# unknown, lot# unknown, qty unknown).This complaint involves (1) device.This report is for (1) 2.7/3.5mm va-lcp medial distal tibia plate/14 holes/right.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Patent identifier: (b)(6).Event year is reported as 2021; however exact date of event is unknown.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: health effect clinical code e2402 used to capture code injury.H3, h6: a product investigation was conducted.Visual inspection: the va-lcp med dis tib, 14 h, rt (part# 02.118.012, lot# l361453) was returned and received at us cq.Upon visual inspection, the the plate was observed to be bent and cracked on the sixth hole to the distal end of the head of tibia plate.No other issues were noted with the returned device.The provided photographs in the pc attachments were reviewed and no additional issues were observed.Dimensional inspection: thickness of plate was measured and found to be conforming per relevant drawing.Document/specification review: based on the manufactured date of the device, the current and manufactured revision of drawings were reviewed.No design issues or manufacturing discrepancies were noted.Investigation conclusion: the complaint is confirmed for the returned device.The bend/crack on the plate potentially is consistent with the fracture not being healed and a consequent trauma applied on the fracture.However, the reported condition of broken could not be confirmed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.H3, h4, h6: a device history record (dhr) review was conducted: part # 02.118.012; lot # l361453; manufacturing site: werk raron; release to warehouse date: 27 mar2017.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/14 HOLES/RIGHT
• 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): 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: 13158931
• Report Number: 2939274-2022-00012
• Device Sequence Number: 12099305
• Product Code: HRS
• UDI-Device Identifier: 10886982037787
• UDI-Public: (01)10886982037787
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• 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,Company Representative
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.118.012
• Device Catalogue Number: 02.118.012
• Device Lot Number: L361453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female