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

Model Number	PATELLA SUTPLT II STAR POLE FRAC S STRL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via phone that an ar-13070s-p-s patella sutureplate¿ ii had an issue.During a oris patella fracture procedure on (b)(6) 2022, when the surgeon was tamping the hooks distally into the patella, one of the distal hooks of the sutureplate bent, so the surgeon tried to grab the hook to bend it to a normal position, and while doing so, one hook on the sutureplate broke completely inside the patient, and the other hook broke partially.The surgeon was able to retrieve and remove all fragments from the patient.Another implant (same part, different unk lot number) was used to complete the procedure successfully with no impact to the patient.
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.

• Brand Name: PATELLA SUTPLT II STAR POLE FRAC S 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: 13994966
• Report Number: 1220246-2022-04683
• Device Sequence Number: 5310218
• Product Code: HRS
• UDI-Device Identifier: 00888867279476
• UDI-Public: 00888867279476
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: PATELLA SUTPLT II STAR POLE FRAC S STRL
• Device Catalogue Number: AR-13070S-P-S
• Device Lot Number: 2114018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 04/04/2022
• Date Device Manufactured: 05/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown