MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI CONDYLAR PLATE 7 HOLES/39MM-LEFT; PLATE, FIXATION, BONE

Model Number	443.61.96
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(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 on (b)(6) 2019, the patient underwent revision surgery due to the broken plate.The 2.0mm/39mm titanium condylar plate and two (2) unknown screws were originally implanted on (b)(6) 2018.The surgeon stated that within 4 weeks the plate had failed by no fault of the patient because the patient was splinted and compliant.The fracture was repaired with another identical plate and screws.It is unknown if there were fragments generated from a broken device.Procedure and patient outcome are unknown.Concomitant device reported: screws (part: unknown; lot: unknown; quantity: unknown).This report is for a 2.0mm titanium (ti) condylar 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.Device history records review was completed for part: 443.61.96, lot: 5365125.Manufacturing location: elmira, manufacturing date: oct 23, 2006.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history records determined the raw material lot met all specifications with no issues documented that would contribute to this complaint condition.Product investigation was completed.The 2.0 mm ti condylar plate 7 holes/ 39 mm- left was received with the plate broken between the second and third hole from the perpendicular rod portion of the device and part of the hole on the broken part of the device is now exposed/open.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional analysis was completed, the inner diameter of the hole close to the fracture site measured 2.24 mm (caliper gp29).This is within specification of 2.2 mm to 2.3 mm, based on drawing.Relevant drawings were reviewed.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative 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: 2.0MM TI CONDYLAR PLATE 7 HOLES/39MM-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: 8597053
• Report Number: 2939274-2019-57934
• Device Sequence Number: 19335525
• Product Code: HRS
• UDI-Device Identifier: 10886982223210
• UDI-Public: (01)10886982223210
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 443.61.96
• Device Catalogue Number: 443.61.96
• Device Lot Number: 5365125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 05/29/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention