MAUDE Adverse Event Report: SYNTHES (USA) 10MM CANNULATED TAPERED DRILL BIT; TEMPLATE

Catalog Number 03.037.021

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Sedation (2368); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.Device is not available for return.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2016, during a right tfna (trochanteric fixation nail advance) procedure, two drill bits broke.The tips broke off and fragments were created.Fragments were removed; however, some tiny fragments may have remained in the patient although an x-ray, irrigation and suctioning were performed.It was noted that it was a "tough" fracture and procedure.The guide wire bent during manipulation to stabilize the fracture.The drill bits did touch the guide wire and was believed to have caused the breakages of drill bits.There was a 30-45 minute delay.The outcome of the procedure was successful and the patient condition was reported as "fine." this is report number 1 of 2 for (b)(4).

• Brand Name: 10MM CANNULATED TAPERED DRILL BIT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6095529
• MDR Text Key: 59718239
• Report Number: 2520274-2016-15348
• Device Sequence Number: 1
• Product Code: HWT
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR