MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SINGLE USE INSTRUMENTS - FEMORAL KIT (CR) - SIZE 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5555-2206

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The surgeon reported that when using the single use precision femoral cutting guide, he noticed that there was a yellow debris in the patient.He used pulse lavage to remove the debris and the surgeon believes that he was successful in removing all the debris from the patient's bone.There were no significant delays to surgery the surgeon reported that he was using standard blades and not precision cutting blades to undertake this case.The optech indicates that standard blades can be used.

Manufacturer Narrative

An event regarding damage and debris intraoperative involving a single use triathlon cutting guide was reported.The event was confirmed.Method & results: device evaluation and results: the 4:1 yellow cutting guide was returned for evaluation.Abrasion marks in the blades slots consistent with saw blade contact was observed.Device history review: there were no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the event was confirmed.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.As indicated in the surgical protocol precis-sp-1, there is a potential for debris generation when using this product.

Event Description

The surgeon reported that when using the single use precision femoral cutting guide, he noticed that there was a yellow debris in the patient.He used pulse lavage to remove the debris and the surgeon believes that he was successful in removing all the debris from the patient's bone.There were no significant delays to surgery update - the surgeon reported that he was using standard blades and not precision cutting blades to undertake this case.The optech indicates that standard blades can be used.

• Brand Name: SINGLE USE INSTRUMENTS - FEMORAL KIT (CR) - SIZE 6
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5661370
• MDR Text Key: 45434860
• Report Number: 0002249697-2016-01621
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K132624
• 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: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Catalogue Number: 5555-2206
• Device Lot Number: 28101401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other