MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER PRECISION OSCILLATING TIP SAW CARTRIDGE (25X1.27X105MM); INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 6425127105

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device was discarded.

Event Description

It was reported that, during a tka (total knee arthroplasty) , when a nurse was opening the package, she noticed a pinhole on it.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

The quality investigation is complete.

Event Description

It was reported that, during a tka (total knee arthroplasty) , when a nurse was opening the package, she noticed a pinhole on it.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: STRYKER PRECISION OSCILLATING TIP SAW CARTRIDGE (25X1.27X105MM)
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; IE NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; IE NA ; 214532900
• MDR Report Key: 9866827
• MDR Text Key: 184732876
• Report Number: 0001811755-2020-00752
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327143744
• UDI-Public: 07613327143744
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: 6425127105
• Device Catalogue Number: 6425127105
• Device Lot Number: 18200017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2018
• 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