MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR.; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-1-705E

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Drill bit got stuck in the cutting block.

Manufacturer Narrative

An event regarding a drill bit got stuck in the cutting block was reported.The event was confirmed during visual and functional evaluations.Method & results: device evaluation and results: a functional analysis confirms the pin could not pass through the guide.A visual inspection showed material transfer.Also the device has been reviewed by a material subject matter expert.It was confirmed that the seizure was caused by galling.Medical records received and evaluation: not performed because patient factors did not contribute to the event.-device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events reported for this manufacturing lot.Conclusions: the investigation concluded that seizure was caused by galling.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Drill bit got stuck in the cutting block.

• Brand Name: SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR.
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 5195931
• MDR Text Key: 30431967
• Report Number: 0002249697-2015-03547
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• 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
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-1-705E
• Device Lot Number: SB9S18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2014
• 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