MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SLAP HAMMER; INSTRUMENT

Catalog Number 6541-4-803

Device Problems Difficult to Remove (1528); Sticking (1597)

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

Event Date 01/21/2013

Event Type  malfunction  

Event Description

It was reported that the surgeon performed a revision tka to replace non stryker knee components.During the surgery, when he was removing the trial components with a slap hammer, the blue handle stuck on the shaft.Therefore, he attempt to remove them with a spare slap hammer.However, it also stuck on the shaft.

Manufacturer Narrative

An event regarding a seized triathlon slap hammer was reported.The event was not confirmed.Visual inspection for the device was unremarkable.Light scratching was observed on the mating features consistent with normal use of the device.Functional inspection of the returned device could not confirm the reported event, the returned device functioned correctly.It was observed that if a torque was applied to the sliding handle of the device while attempting to slide the handle the reported event could be reproduced.As this device is intended for axial impaction it is not intended to be torqued and this would be considered misuse of the instrument.Dimensional inspection of the shaft of the device confirmed that the component was within drawing specification.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.It was noted that all devices in the subject lot passed a functional check at the time of manufacture.Complaint history review found no other events have been reported for the manufacturing lot.The investigation concluded that the reported binding of the device was caused by user factors.The event could be reproduced by applying a torque to the sliding handle of the device while attempting to slide the handle.This device is intended for axial impaction and as such the application of torque is considered misuse of the instrument.

• Brand Name: SLAP HAMMER
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3752000
• MDR Text Key: 4550878
• Report Number: 0002249697-2014-01187
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-4-803
• Device Lot Number: MC4M02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2013
• 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