MAUDE Adverse Event Report: ARTHREX, INC. SCRWDRV,CANN.,PINLOCK II,3.5MM HEX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SCRWDRV,CANN.,PINLOCK II,3.5MM HEX
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/27/2019
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 was reported during an acl procedure the tip of the driver broke off in the patient.The driver tip was stuck in the screw and could not be retrieved.Reporter stated the screw was seated and all is secure.Per reporter, the patient is fine to date and the doctor feels there is no need for a revision.
Additional Manufacturer Narrative
Complaint confirmed, the tip was found to be twisted and broken.The most likely causes of the event are continually applying torque, prying and/or leveraging the device.

• Brand Name: SCRWDRV,CANN.,PINLOCK II,3.5MM HEX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9473440
• Report Number: 1220246-2019-01491
• Device Sequence Number: 10815238
• Product Code: LXH
• UDI-Device Identifier: 00888867022423
• UDI-Public: 00888867022423
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: SCRWDRV,CANN.,PINLOCK II,3.5MM HEX
• Device Catalogue Number: AR-1896
• Device Lot Number: 1498090912
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other