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 Detachment Of Device Component (1104); Mechanical Problem (1384)

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

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Pin came off the back of the triathlon size 5 4:1 cutting block after cuts had been made and while block was being extracted.Surgeon noticed this as the block was being taken out.

Manufacturer Narrative

Reported event: an event regarding pin disassociation of a triathlon guide was reported.The event was confirmed.Method & results: -device evaluation and results: device was not returned however, an image of the device was provided that shows some blood stains and disassociated peg from the assembly.-medical records received and evaluation: not performed as there was no indication that patient factors contributed to the reported event.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other events for the lot referenced.Conclusions: the investigation concluded that the fixation peg disassociating from the triathlon cutting block was caused by a manufacturing nonconformance.It was concluded that the supplier had not performed the required press fit operation between the peg and block which led to the pin coming out of the assembly.Stryker reserves the right to re-evaluate this investigation if additional relevant information becomes available.Not returned to the manufacturer.

Event Description

Pin came off the back of the triathlon size 5 4:1 cutting block after cuts had been made and while block was being extracted.Surgeon noticed this as the block was being taken out.

• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6105361
• MDR Text Key: 60033695
• Report Number: 0002249697-2016-03618
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• 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: SB5H15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2010
• 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