MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T-15, LONG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T-15, LONG
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2021
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 the screw (ar-9145-30, lot 19.02683) could be inserted completely, but the tip of the device (ar-9545-115-03) broke during the final tightening and the tip remained inside the patient within the head of the screw.The device was already bent during the insertion of the previous screw.According to the surgeon there was no harm for patient, operator or third party.The implantation of a universal glenoid surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update 19-apr-2021: it was confirmed that broken device remaining inside the patient was used to finish the procedure and no additional incisions were necessary.
Additional Manufacturer Narrative
The complaint could not be confirmed.As the complaint device was not returned for investigation, a review of the picture provided was performed.Based on the picture provided, it can be seen that the distal tip of the ar-9545-t15-03 is twisted, but it cannot be determined by the picture if the tip is broken off or not.Additionally a fragment of the ar-9145-30 screw is in the picture, the proximal end of the head.As the device was not returned for investigation it cannot be determined by the picture if the tip is broken off or not.

• Brand Name: DRIVER SHAFT, T-15, LONG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11761335
• Report Number: 1220246-2021-02998
• Device Sequence Number: 19121080
• Product Code: LXH
• UDI-Device Identifier: 00888867225176
• UDI-Public: 00888867225176
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• 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: DRIVER SHAFT, T-15, LONG
• Device Catalogue Number: AR-9545-T15-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 10/13/2021
• Patient Sequence Number: 1