MAUDE Adverse Event Report: ARTHREX INC. NONCANNULATED SHORT SCREWDRIVER SHAFT, 2.5 MM HEX, 5.5 MM X 17 CM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	AR-1995SHN
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not yet returned therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Complainant's event was most likely caused by prying/leveraging the driver during the implant removal process.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient reinjured her acl and required a revision.During the revision the surgeon attempted to remove an arthrex screw (part number unknown) and the tip of the screw drive broke off in the head of the screw.The screw was not in a place where it would interfere with the revision so it was left along with the tip of the driver.The surgeon implanted an ar-1588btb to complete the revision with no further issues other than a slight delay in the case.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is a follow-up submission due to device evaluation.Complaint confirmed.The evaluation revealed that the driver's hex was twisted and sheared off.Complainant's event typically caused by continually applying torque after the screw is fully seated, torquing when the implant is not properly aligned, torquing while leveraging the device and/or using the incorrect screw with the driver (screw does not seat fully on the driver).Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient reinjured her acl and required a revision.During the revision the surgeon attempted to remove an arthrex screw (part number unknown) and the tip of the screw drive broke off in the head of the screw.The screw was not in a place where it would interfere with the revision so it was left along with the tip of the driver.The surgeon implanted an ar-1588btb to complete the revision with no further issues other than a slight delay in the case.

• Brand Name: NONCANNULATED SHORT SCREWDRIVER SHAFT, 2.5 MM HEX, 5.5 MM X 17 CM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6913256
• Report Number: 1220246-2017-00365
• Device Sequence Number: 1041548
• Product Code: LXH
• UDI-Device Identifier: 00888867025684
• UDI-Public: 00888867025684
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: AR-1995SHN
• Device Lot Number: 10077394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other