MAUDE Adverse Event Report: PATELLA SUTPLT II ARROW STRL; PLATE, FIXATION, BONE

Model Number	PATELLA SUTPLT II ARROW STRL
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
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 on 8/24/2021 by a sales rep via email that an ar-1370a-s patella sutureplate¿ ii was being used in a case.After placing two 4.0 cannulated screws and fibertape to revise a transverse patella fracture, the surgeon wanted to add a plate to increase stability due to the patient's previous lack of compliance.After choosing the arrow suture plate, the surgeon was unable to lock the screws successfully in the plate.The screws were not sitting flush, which caused the surgeon to abandon use of the plate and rely on the cannulated screws and fibertape he utilized at the beginning of the case.*additional information requested.Additional information provided 8/30/2021: dos is (b)(6) 2021, date of revision is (b)(6) 2021.The patient fell on the operative leg shortly after surgery, thus refracturing her patella which is the reason for the revision.During the revision, the surgery explanted the previously placed 4.0 cannulated screws and fibertape (ar-5051-30, ar-5051-34, ar-7237-17ln).
Additional Manufacturer Narrative
Complaint could not be confirmed.Visual evaluation identified no product issue.The plate was in good condition.However, the associated screws were not returned for investigation and, therefore, functional testing cannot be performed.

• Brand Name: PATELLA SUTPLT II ARROW STRL
• Common Device Name: PLATE, FIXATION, BONE
• MDR Report Key: 12467357
• Report Number: 1220246-2021-03642
• Device Sequence Number: 19767072
• Product Code: HRS
• UDI-Device Identifier: 00888867279438
• UDI-Public: 00888867279438
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 10/28/2021

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: 04/30/2026
• Device Model Number: PATELLA SUTPLT II ARROW STRL
• Device Catalogue Number: AR-13070A-S
• Device Lot Number: 2121040
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other