MAUDE Adverse Event Report: SYNTHES USA MATRIX 1.1MM DRILL BIT J-LATCH/8MM STOP/44.5MM

Catalog Number 03.503.248

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure the tip of the 1.5 mm drill bit broke off.The drill bit was stuck in the skull of the patient.The surgeon was using the bit as a sound, it was not moving he did not move on it or pull on it, and it snapped.The broken fragments were retrieved.There was a delay of less than 60 seconds.The procedure was successfully completed.This report is 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device is used for treatment, not diagnosis additional codes: erl, hbe.Device is an instrument and is not implanted/explanted.Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.Placeholder.

Manufacturer Narrative

(b)(4): the part has been returned, an evaluation is pending.

Manufacturer Narrative

The returned matrix 1.1mm drill bit was returned with visible sign of a broken distal tip.Based on the returned product the root cause of is unknown.Probable root causes include mechanical overloading by caregiver or high bone density of the patient, but it is unclear what truly caused the product to fail.For this instrument, predrilling is recommended with 1.1 mm matrix drill bits for 3mm ¿ 8mm lengths in areas of dense bone, it might be necessary to pre-drill when using self-drilling screws.A review of the most current revision of drawing document completed.The material and design are adequate for its intended use and did not contribute to reported complaint.Therefore, this complaint is invalid from a design standpoint.Based on the returned product the root cause of the product is unknown.Probable root causes include mechanical overloading by caregiver or high bone density of the patient but it is unclear what truly caused the product to fail.Although the root cause is unknown, the design was reviewed and did not contribute to the failure of product; therefore, this complaint is invalid from a design standpoint.

• Brand Name: MATRIX 1.1MM DRILL BIT J-LATCH/8MM STOP/44.5MM
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3623261
• MDR Text Key: 4177631
• Report Number: 2520274-2014-00523
• Device Sequence Number: 1
• Product Code: DZI
• Combination Product (y/n): N
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR