MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MIS FEMORAL ADJUSTMENT BLOCK; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-5-601

Device Problems Difficult or Delayed Positioning (1157); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

After opening the items has been noticed that it's very difficult to move it between the relevant scales.Not suitable for nurse usage during surgery.

Manufacturer Narrative

An event regarding a mechanical issue involving a mis femoral adjustment block was reported.The event was confirmed.Method & results: device evaluation: the device was returned with no apparent deformities.A functional test confirmed the event.However, after the application of lubricant, device adjustment was smooth.Clinician review: not performed as medical records were not received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the event was confirmed as the device was difficult to adjust as it was received.This device was returned along with another device with the same catalog number regarding the same issue in the same surgery.After applying lubricant to both devices, device adjustment was very easy.The instructions for use of the device calls for the application of lubricant on all articulating surfaces of the device before device sterilization.As per the results of the functional test performed after lubricating the devices, there is evidence to suggest that the instructions for use were not followed.If additional information is received, this investigation will be reopened and re-evaluated.

Event Description

After opening the items has been noticed that it's very difficult to move it between the relevant scales.Not suitable for nurse usage during surgery.

• Brand Name: MIS FEMORAL ADJUSTMENT BLOCK
• 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: 5365018
• MDR Text Key: 35920625
• Report Number: 0002249697-2016-00053
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-5-601
• Device Lot Number: RD9S005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2014
• 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