MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA-LCP DISTAL TIBIA L-PLATE/4 HOLES/LEFT; PLATE, FIXATION, BONE

Model Number	02.118.303
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr , device manufacture date : 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 variable angle (va) locking compression plate (lcp) distal tibial plate broke in the patient's foot.The device was implanted on (b)(6) 2020.Currently the patient is not scheduled to have the plate removed.This report is for a va-lcp distal tibial plate.This is report 1 of 1 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: a1; b6; b7.H6: photo investigation: the device was not returned for investigation.A photo investigation was completed on the x-rays provided in the document.Upon analysis of the x-rays, the variable angle lcp distal tibial plates was found broken.The potential cause of the issue could not be determined, and an assignable root cause was not identified from the available.A manufacturing record evaluation could not be performed as no lot number information was available.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 can be confirmed based on the x-rays 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.
Event or Problem Description
It was further reported that initially patient had a left pilon ankle fracture and left proximal humerus fracture due to fall of a ladder.The left pilon ankle fracture was treated with implantation of variable angle (va) locking compression plate (lcp) distal tibial plate on (b)(6) 2020.
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.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.H10 additional narrative: b4 - date of this report b6 - tests/lab data including dates.B7 - medical history/preexisting condition.Photo investigation: the device was not returned for investigation.A photo investigation was completed on the x-rays provided in the document titled ¿(b)(4)¿ on pages 105-113.Upon analysis of the x-rays, the variable angle lcp distal tibial plates was found broken.The potential cause of the issue could not be determined, and an assignable root cause was not identified from the available.A manufacturing record evaluation could not be performed as no lot number information was available.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 can be confirmed based on the x-rays 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 history review - dhr review could not be performed as no lot number information was available 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: 2.7MM VA-LCP DISTAL TIBIA L-PLATE/4 HOLES/LEFT
• 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: 12173175
• Report Number: 2939274-2021-04109
• Device Sequence Number: 960935
• Product Code: HRS
• UDI-Device Identifier: 10886982038685
• UDI-Public: (01)10886982038685
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.118.303
• Device Catalogue Number: 02.118.303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/23/2021; 08/15/2021; 10/19/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/12/2021; 09/13/2021; 10/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention