MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXRIB UNIVERSAL PLATE 8 HOLES; PLATE, FIXATION, BONE

Model Number	04.501.009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter is synthes sales representative without a lot number the device history records review could not be completed.Product was not returned.(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) 2020, the broken titanium matrixrib universal plate was replaced.The plate broke on the patient on an unknown date.Procedure and patient outcome are unknown.Concomitant devices reported: unknown screws: trauma (part# unknown, lot# unknown, quantity# unknown).This report is for one (1) ti matrixrib universal plate 8 holes.This is report 1 of 1 for (b)(4).

• Brand Name: TI MATRIXRIB UNIVERSAL PLATE 8 HOLES
• 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: 9856076
• Report Number: 2939274-2020-01375
• Device Sequence Number: 14241430
• Product Code: HRS
• UDI-Device Identifier: 10887587017082
• UDI-Public: (01)10887587017082
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K161590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: 04.501.009
• Device Catalogue Number: 04.501.009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention