MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T10 HEXALOBE, CANNULATED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T10 HEXALOBE, CANNULATED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
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.
Event or Problem Description
It was reported that the tip of the ar-8737-16 broke off during insertion.The sales rep reported all broken fragments were fully retrieved.There was no negative outcome, and the case was completed by using another driver.
Additional Manufacturer Narrative
Complaint confirmed, the ar-8737-16 returned has a twisted and broken drive feature.The device is missing approximately.05 in.Relevant features could not be measured because of the damage and deformation, however review of the certificate of conformance reveals the device meets material specifications.The cause of the event is undetermined.Likely causes included overtorquing the device; prying/leveraging during use; shallow driver engagement depth.
Additional Manufacturer Narrative
Complaint confirmed, the ar-8737-16 returned has a twisted and broken drive feature.The device is missing approximately.05 in.Relevant features could not be measured because of the damage and deformation, however review of the certificate of conformance reveals the device meets material specifications.The cause of the event is undetermined.Likely causes included overtorquing the device; prying/leveraging during use; shallow driver engagement depth.

• Brand Name: DRIVER SHAFT, T10 HEXALOBE, CANNULATED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11627302
• Report Number: 1220246-2021-02840
• Device Sequence Number: 3015629
• Product Code: LXH
• UDI-Device Identifier: 00888867046115
• UDI-Public: 00888867046115
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2021

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, T10 HEXALOBE, CANNULATED
• Device Catalogue Number: AR-8737-16
• Device Lot Number: 1391820
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 03/17/2021; 03/17/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 06/04/2021; 06/08/2021
• Patient Sequence Number: 1