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U.S. Department of Health and Human Services

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

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ARTHREX, INC. PATELLA SUTPLT II STAR M STRL PLATE, FIXATION, BONE Back to Search Results
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.
 
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Brand NamePATELLA SUTPLT II STAR M STRL
Type of DevicePLATE, 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 Key13333358
MDR Text Key284348407
Report Number1220246-2022-04308
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K203834
Number of Events Reported1
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 Received01/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPATELLA SUTPLT II STAR M STRL
Device Catalogue NumberAR-13070M-S
Device Lot Number2123051
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/06/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/24/2022 Patient Sequence Number: 1
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