MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 4.0MM DRILL 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2107-4025

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983); Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Doctor had already inserted the tritanium cup and wanted to place a couple of screws.As he turned the drill on with the 25mm x 4mm trident drill in the 4mm drill guide the drill 'jammed' or locked up in the guide.It took a few minutes to try and dislodge the drill from the guide but it wouldn't come out.

Manufacturer Narrative

Device not returned for evaluation.An event regarding a seized trident drill bit was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned for inspection.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar previous reported events.Conclusions: the exact cause of the event could not be determined because the device was not returned for inspection.No further investigation for this event is possible at this time.If the devices become available, this investigation will be reopened.

Event Description

Doctor had already inserted the tritanium cup and wanted to place a couple of screws.As he turned the drill on with the 25mm x 4mm trident drill in the 4mm drill guide the drill 'jammed' or locked up in the guide.It took a few minutes to try and dislodge the drill from the guide but it wouldn't come out.

• Brand Name: 4.0MM DRILL 25MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5246633
• MDR Text Key: 32146713
• Report Number: 0002249697-2015-04005
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K151264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

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: 2107-4025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other