MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR.; INSTRUMENT

Catalog Number 6541-1-705E

Device Problems Detachment Of Device Component (1104); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a primary left knee, the fixation peg came off the cutting block off during surgery.Surgeon made cuts and put handle on to remove the cutting block.When removed, one of the fixation pegs was stuck in patient's bone as it came off of the cutting block.Surgeon removed with small pliers.No delay in case or any adverse consequence to patient.

Manufacturer Narrative

An event regarding pin dissociation from a triathlon cutting guide was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as there was no indication that patient factors contributed to the reported event.Device history review: all devices accepted into final stock conformed to specification.This review confirmed the device was manufactured prior to capa implementation.Complaint history review: there have been similar reported events for the reported lot id.Conclusions: although the device was not returned, the description is consistent with similar events where the fixation peg disassociating from the triathlon cutting block.Previous events identified the cause to be 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.As a result, nonconformance pr was previously raised.The supplier investigation, scope and corrective actions are detailed within the nc and corresponding capa pr.

Event Description

It was reported that during a primary left knee, the fixation peg came off the cutting block off during surgery.Surgeon made cuts and put handle on to remove the cutting block.When removed, one of the fixation pegs was stuck in patient's bone as it came off of the cutting block.Surgeon removed with small pliers.No delay in case or any adverse consequence to patient.

• Brand Name: SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR.
• 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: 4936415
• MDR Text Key: 22692506
• Report Number: 0002249697-2015-02423
• 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: health professional,other
• Reporter Occupation: Other
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• 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: SB2V23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2008
• 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