MAUDE Adverse Event Report: SYNTHES USA 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM

Catalog Number 357.403

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2014

Event Type  malfunction  

Event Description

It was reported that a drill bit broke during a procedure in the canal of the patient and that the surgeon was not able to retrieve all broken fragments.This did not affect the outcome of procedure.It was also reported that the drill bit was fatigued and might have had a stress fracture.There were two remaining pieces of metal in the femoral neck and surgeon elected to leave the fragments in the patient.There was no harm to the patient.The procedure was successfully completed without any delay.No additional information was provided.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device in an instrument and is not implanted/explanted.The lot number provided could not be verified.Placeholder.

Manufacturer Narrative

Additional narrative: orchid unique manufactured the 6.0mm/10.0mm step drill bit cannulated/large qc/435mm, p/n 357.403, and lot number up53250.The material and heat treat values of the drill bit were confirmed to be correct.The cannulation diameter was confirmed to be within specifications, and damage prevented verification of the outer diameter.The part conformed to all inspection requirements at incoming final inspection.Based on the specifications at the time of the original manufacturing, the unknown root cause, and the evaluation performed by synthes, this complaint is deemed invalid from a manufacturing position.The drill is an important part of the trochanteric fixation nail system used for the intramedullary fixation of proximal femur fractures and specifically the creation of the necessary pilot hole required for all helical blades for proximal locking of the trochanteric fixation nail.The returned device is broken and admittedly became so during use.The complaint description alleges that it may have contained stress fractures prior to use and ultimate breakage.It is likely that the drill may also have come into contact with the guide wire during use which ultimately caused it to fracture and fail.Drawing 357_403 revision e was reviewed and determined to be suitable for the intended design, application and dimensional conformity.The devices method of use and condition has likely led to this complaint and was not a result of a design deficiency.The device is determined to be suitable for this intended use and the complaint is invalid from a design perspective.

• Brand Name: 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: renan pena ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3586935
• MDR Text Key: 4141607
• Report Number: 2520274-2014-00285
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2014

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: 357.403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 01/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2014
• 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: 51 YR