MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM NARROW LC-DCP PLATE 10 HOLES/178MM; PLATE, FIXATION, BONE

Model Number	224.60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on an unknown date, the patient underwent revision of a midshaft nonunion in the left humerus and right tibia.In patient's humerus, dynamic compression plates with limited bone contact (lc-dcp) and narrow dynamic compression plates with limited bone contact (lc-dcp) were removed, along with twelve cortex screws.Patient was revised to a new lcdcp large fragment plate and bone graft harvested from the patient¿s tibia.In patient's tibia, locking compression plate (lcp) and locking compression plate (lcp) tubular plate were removed, along with twenty-one cortex screws.A ria was used in the tibia to retrieve bone graft.Surgeon corrected the deformity, and patient¿s tibia was revised with a tibial nail advanced, and placement of new screws in remaining two plates.Fragment were generated and was removed easily.The procedure was successfully completed with five minutes surgical delay.This report is for one (1) 4.5mm narrow lc-dcp plate 10 holes/178mm.This is report 36 of 42 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.H10 additional narrative: h3, h6: photo investigation: the part was not returned for investigation.A photo investigation was carried out using the x-rays.The part was removed from the patient body due to a non-union of the left humerus and right tibia.There appears to be no issue with the part from the x-rays provided.A root cause of the issue cannot be determined from the provided information.A manufacturing record evaluation cannot be done as there is no available lot information.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.Conclusion: the complaint condition cannot be confirmed based on the image provided.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: 4.5MM NARROW LC-DCP PLATE 10 HOLES/178MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11999839
• Report Number: 2939274-2021-02959
• Device Sequence Number: 16996871
• Product Code: HRS
• UDI-Device Identifier: 10886982158536
• UDI-Public: 10886982158536
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 224.60
• Device Catalogue Number: 224.60
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention