MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,TI,3.0MMX 20MM; SCREW, FIXATION, BONE

Model Number	LO-PRO LOCK SCRW,TI,3.0MMX 20MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2019
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.
Event or Problem Description
It has been reported that a patient had undergone a previous knee surgery using another manufacturer¿s product.Approximately one week later the patient then underwent a revision procedure using an arthrex patella sutureplate star small, on (b)(6) 2019 (case (b)(4)).At time of surgery the inter-operative x-ray looked good.However, one day after the surgery it was noticed on a second x-ray that the fracture gap was open and too far apart.The patient was scheduled for a revision surgery.On (b)(6) 2019 the patient underwent a revision procedure to remove the following implants: ar-13059s (lot 6045180600 - qty1) patella sutureplate star small (not sold in us); ar-8935l-22 (lot w46320 - qty 2) locking screw; ar-8935l-20 (lot 10224133 -qty 3) locking screw; ar-8935l-20 (lot 1009169 - qty 1) locking screw; ar-8935l-18 (lot 1011926 -qty 1) locking screw; ar-8935l-18 (lot w584981 -qty1) locking screw.To complete the revision procedure the surgeon implanted an arthrex patella sutureplate ii (size l) with corresponding arthrex screws.The surgeon took an x-ray and noticed that the size l plate was too big.Surgeon removed the patella sutureplate ii (size l) and screws.Surgeon then changed the patella sutureplate ii to size m using different screws.Since so many screws were opened during the procedure it was unknown which screws were used and removed with the size l patella sutureplate ii and which were used with the size m patella sutureplate ii and left in the patient.The following is the size m patella sutureplate ii part number and list of all screws that were opened and used during the procedure.Ar-13070m-p-s (lot 1448182600 -qty 1) patella sutureplate ii star pole fracture m (not sold in us); ar-8933l-22 (lot 31807 - qty 4) low profile locking screw; ar-8933l-20 (lot 1047007 - qty 3) low profile locking screw; ar-8933l-20 (lot w5456511 - qty 1) low profile locking screw; ar-8933l-18 (lot 1047304 - qty 4) low profile locking screw.It has since been reported that patient underwent another revision on (b)(6) 2019 which took place at a different facility using another manufacturer¿s system.

• Brand Name: LO-PRO LOCK SCRW,TI,3.0MMX 20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8930467
• Report Number: 1220246-2019-01268
• Device Sequence Number: 227398
• Product Code: HWC
• UDI-Device Identifier: 00888867050082
• UDI-Public: 00888867050082
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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 Model Number: LO-PRO LOCK SCRW,TI,3.0MMX 20MM
• Device Catalogue Number: AR-8933L-20
• Device Lot Number: 1047007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 08/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other