MAUDE Adverse Event Report: ARTHREX, INC. STEP DRILL, BIO-SUTURETAK; BIT, DRILL

Catalog Number AR-1934D-24

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/14/2016

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 contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The device history record review cannot be performed as the lot number is unknown.If the device is returned and additional information is obtained, a follow-up report will be submitted.

Event Description

It was reported via a medwatch ((b)(4)) that the drill bit broke off in the bone and that the surgeon left it in because it reportedly would cause more harm trying to retrieve the broken piece than leaving it in.X-ray performed on area to determine action.It was an arthrex 2.4 suture tak drill bit, ar-1934d-24.Report states they are aware of no patient injury at the time.

• Brand Name: STEP DRILL, BIO-SUTURETAK
• Type of Device: BIT, DRILL
• 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: 6132363
• MDR Text Key: 61060728
• Report Number: 1220246-2016-00523
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00888867024045
• UDI-Public: 00888867024045
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2016

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-1934D-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other