MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 1/8" DRILL W/O STOP - 2/PKG; INSTRUMENT

Catalog Number 3170-0000

Device Problem Sticking (1597)

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

Event Date 04/15/2015

Event Type  malfunction  

Event Description

The sales rep reported that when dr.Fixated the 1/8¿ hex drill stop (3170-0000) into the triathlon revision box cutting guide (6543-1-710) the hex drill stop got stuck.It could not be removed from the box cutting guide.The cutting guide with the attached hex dril where removed without delay.

Event Description

The sales rep reported that when dr.Fixated the 1/8¿ hex drill stop (3170-0000) into the triathlon revision box cutting guide (6543-1-710) the hex drill stop got stuck.It could not be removed from the box cutting guide.The cutting guide with the attached hex drill where removed without delay.

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot.Visual inspection: the drill was returned disassembled from the cutting guide.Spiral scratches were observed on a portion of the drill¿s outside diameter.Visual inspection by the material analysis team indicated that the spiral scratches observed on the drill¿s outside diameter suggest there was galling of the drill against the inside diameter of the cutting guide.This is likely the reason the drill became stuck within the guide.Functional inspection: the drill was inserted into all the holes on the cutting guide.The drill moved through the holes with some resistance due to the spiral scratches on the drill.Conclusions: the investigation determined the drill got stuck i the cutting guide likely due to galling between the two devices.The exact root cause of the galling could not be determined.If additional information becomes available, this investigation will be reopened.

• Brand Name: 1/8" DRILL W/O STOP - 2/PKG
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4765196
• MDR Text Key: 5950469
• Report Number: 0002249697-2015-01512
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2015

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: 3170-0000
• Device Lot Number: RD4M25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other