MAUDE Adverse Event Report: ARTHREX, INC. PATELLA SUTPLT II STAR M STRL; PLATE, FIXATION, BONE

Model Number	PATELLA SUTPLT II STAR M STRL
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that an arthrex plate from the loaner set mth-14120-patplate2 // 403793667 was implanted in an elderly patient.The plate broke post-op due to a fall on the operated knee.A new loaner set was ordered to perform a revision surgery.Update 04-jan-2022: further information was provided that the arthrex plate is not broken.As a result of the fall, the distal pole of the patella is also fractured, means the initial fracture has widened.Due to the new fracture conditions, it was necessary to change to a new arthrex implant, patella suture plate with hook for pole refixation.The revision surgery took place on (b)(6) 2021 the initial surgery took place on (b)(6) 2021.

• Brand Name: PATELLA SUTPLT II STAR M STRL
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13333358
• Report Number: 1220246-2022-04308
• Device Sequence Number: 4100403
• Product Code: HRS
• UDI-Device Identifier: 00888867279452
• UDI-Public: 00888867279452
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/24/2022

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 Expiration Date: 05/31/2026
• Device Model Number: PATELLA SUTPLT II STAR M STRL
• Device Catalogue Number: AR-13070M-S
• Device Lot Number: 2123051
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/24/2022
• Date Device Manufactured: 07/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown