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

Model Number PATELLA SUTPLT II STAR M STRL

Device Problems Break (1069); Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 12/28/2021

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 284348407
• Report Number: 1220246-2022-04308
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867279452
• UDI-Public: 00888867279452
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K203834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/04/2022
• Date Device Manufactured: 07/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other