MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH #5 4:1 CUTTING BLOCK; INSTRUMENT

Catalog Number 6541-1-705

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

The customer reported via the regional sales manager that the pin became stuck in the patient's femur when the cutting block was removed.The customer reported that the surgeon had positioned the cutting block and completed the femoral cut as normal but when he moved the device away from the femur, one of the pins came away from the device and became stuck in the patient's bone.The customer reported that the pin was removed by the surgeon with ease and as the cut had already been made, there were no delays to surgery and the procedure was completed successfully with no adverse consequences.

Manufacturer Narrative

An event regarding a fixation peg disassociating from a #5 4:1 cutting block was reported.The event was not confirmed.There is no indication that this event is related to patient factors.The exact cause of the event could not be determined because of a lack of information.Further information such as the reported device and the lot code are needed to complete the investigation for determining the root cause.

Event Description

The customer reported via the regional sales manager that the pin became stuck in the patient's femur when the cutting block was removed.The customer reported that the surgeon had positioned the cutting block and completed the femoral cut as normal but when he moved the device away from the femur, one of the pins came away from the device and became stuck in the patient's bone.The customer reported that the pin was removed by the surgeon with ease and as the cut had already been made, there were no delays to surgery and the procedure was completed successfully with no adverse consequences.

Manufacturer Narrative

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

• Brand Name: #5 4:1 CUTTING BLOCK
• 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: 3763442
• MDR Text Key: 4571034
• Report Number: 0002249697-2014-01426
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-1-705
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: No
• 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