MAUDE Adverse Event Report: ARTHREX, INC. LOW PROF SCRW,SS 4.0X 46MMCANN,SHT THD; SCREW, FIXATION, BONE

Model Number	LOW PROF SCRW,SS 4.0X 46MMCANN,SHT THD
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/09/2021
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 that during an elbow procedure, when the surgeon was implanting the ar-8840c-46, 4.0 x 46 pt cannulated screw, the head snapped clean off the shaft of the screw.The surgeon was able to remove the shaft out of the patient, but the surgeon is concerned on the integrity of the screw.No patient harm reported at this time.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation identified that the head of the screw had broken off.Additionally, the screw shaft was found to be bent.Due to the damaged state of the screw, functional testing and accurate measurement analysis could not be conducted.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: LOW PROF SCRW,SS 4.0X 46MMCANN,SHT THD
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12392624
• Report Number: 1220246-2021-03575
• Device Sequence Number: 4181496
• Product Code: HWC
• UDI-Device Identifier: 00888867048089
• UDI-Public: 00888867048089
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• 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): 10/13/2021

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 Model Number: LOW PROF SCRW,SS 4.0X 46MMCANN,SHT THD
• Device Catalogue Number: AR-8840C-46
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1