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

Catalog Number AR-9545-T15-03

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2017

Event Type  Injury  

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 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.Device history record review revealed nothing relevant to this event.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device requested but not yet received.

Event Description

It was reported that screwdriver broke during insertion of the central screw.Tip of screwdriver could not be removed from head of the central screw.Tip of the screwdriver fragment sits flush with the surface of the screw.Tip of screwdriver is secured by glenosphere.Surgery was successfully finished, no adverse conditions.

Manufacturer Narrative

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.Device history record review revealed nothing relevant to this event.Complaint confirmed.The device met all material specifications as received.The evaluation revealed a torsional break on the tip of the driver typically caused when excessive force is being applied on the device during use and/or over-torquing when the screw is already seated.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that screwdriver broke during insertion of the central screw.Tip of screwdriver could not be removed from head of the central screw.Tip of the screwdriver fragment sits flush with the surface of the screw.Tip of screwdriver is secured by glenosphere.Surgery was successfully finished, no adverse conditions.Follow-up investigation: torque limiter ar-9545-t15 was not available and not used.

• Brand Name: DRIVER SHAFT, T-15, LONG
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6459684
• MDR Text Key: 71684225
• Report Number: 1220246-2017-00119
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867225176
• UDI-Public: 00888867225176
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: AR-9545-T15-03
• Device Lot Number: 8001636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other