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

Model Number	02.118.212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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.(b)(4).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 (b)(6) 2019, patient required a revision due to a broken 2.7/3.5 14-hole right variable angle locking compression plate (va-lcp) anterolateral distal tibia curved angle plate.Post-operative, the patient heard a "pop" noise and then fell.It was noted that the plate broke (unknown date).The patient was revised with an ex fix.No issues were noted during the revision.The broken plate was discarded by the operating room staff in the bio-hazard bin at the hospital.Concomitant devices; screws (part: unknown, lot: unknown, quantity: unknown).This report is for a 2.7/3.5mm va-lcp anterolateral distal tibia plate.This is report 1 of 1 for (b)(4).
Event or Problem Description
07/5/2019: updated event description: it was reported that on (b)(6) 2019, the patient underwent revision of a variable angle locking compression plate anterolateral distal tibia plate to an external fixator.On an unknown date, it was noted that the patient heard a "pop" noise and the plate fell twice then broke.The plate was removed.The broken plate was very easily removed.No issues were noted during the revision.There was no backup plate needed.There was no fragments, surgical delay, other devices involved, the procedure was successfully completed.There were no fragments and no other devices involved.Patient outcome is unknown.Concomitant device reported: unknown screws (part# unknown, lot # unknown, quantity # unknown).This complaint involves one (1) device.
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.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.

• Brand Name: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/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
• MDR Report Key: 8771076
• Report Number: 2939274-2019-59063
• Device Sequence Number: 13870269
• Product Code: HRS
• UDI-Device Identifier: 10886982038500
• UDI-Public: (01)10886982038500
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 02.118.212
• Device Catalogue Number: 02.118.212
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 07/31/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention