MAUDE Adverse Event Report: SYNTHES BETTLACH 6.0MM DRILL BIT/QC/195MM; INSTR, SURGICAL, ORTHO, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number 310.600

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/15/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during the removal of a hip head necrosis surgery the drill bit broke.The broken fragment remained in patient.There was no delay in the procedure.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional product code: htw.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.The lot number provided could not be verified; therefore, further investigation cannot be performed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A device history review was conducted.The report indicates that no ncrs were generated during production.There were no issues during the manufacture of the product that would contribute to this complaint condition.A manufacturing investigation was conducted.The report indicates that the investigation of the complained drill bit has shown that the tip is broken off due to a momentary overload.The cause of the overload can not be definitely determined.The load limit of the material has been exceeded by an unintended bending moment and finally led to a breakage.The fracture surface is homogeneous, indicating a proper quality of material.No product fault could be detected.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 6.0MM DRILL BIT/QC/195MM
• Type of Device: INSTR, SURGICAL, ORTHO, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA 19380 CH2; SZ 19380 CH25
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3917469
• MDR Text Key: 4489121
• Report Number: 2520274-2014-12420
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK962913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.600
• Device Lot Number: 2010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 07/07/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/19/2014; 03/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/1986
• 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 Age: 58 YR