MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE #6 4-IN-1 CUTTING BLOCK CAPTURED ASSY TRIA. EXP. INSTR.; KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

Catalog Number 6541-1-706E

Device Problems Disassembly (1168); Entrapment of Device (1212); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

Whilst extracting the #6 express femoral 4:1 cutting guide from the femur a peg remained insitu on the condyli of the patient.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding pin dissociation of a triathlon 4:1 express cutting guide was reported.The event was confirmed.Inspection of the returned device confirmed the pin had dissociated from the device body.Additional dimensional inspection was not performed as it was confirmed the product was within scope.Clinical factors did not contribute to the reported event.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 this lot id.The investigation concluded that the fixation peg disassociating from the triathlon 4:1 express cutting block was caused by a manufacturing nonconformance.It was concluded that the supplier, (b)(4), had not performed the required press fit operation between the peg and block which led to the pin coming out of the assembly.

Event Description

Whilst extracting the #6 express femoral 4:1 cutting guide from the femur a peg remained insitu on the condyl of the patient.

Manufacturer Narrative

Upon file review, it was noted this event was inadvertently reported as a serious injury.There was no patient injury or adverse consequences reported, therefore b1 and h1 have been corrected to indicate device malfunction.

Event Description

Whilst extracting the #6 express femoral 4:1 cutting guide from the femur a peg remained insitu on the condyl of the patient.Update: the peg was removed and returned to the manufacturer doe evaluation.

• Brand Name: SIZE #6 4-IN-1 CUTTING BLOCK CAPTURED ASSY TRIA. EXP. INSTR.
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3686458
• MDR Text Key: 4303164
• Report Number: 0002249697-2014-00800
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-1-706E
• Device Lot Number: SB3M87
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2008
• 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
• Patient Age: 72 YR
• Patient Weight: 98