MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.19X110.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL.

Model Number 6118119110

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a potential sterility breach on the packaging of the device, prior to a procedure, the inner polybag was merged into the seal of the outer package.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

Manufacturer Narrative

H6: the quality investigation is complete.H3 other text : device discarded.

Event Description

It was reported that there was a potential sterility breach on the packaging of the device, prior to a procedure, the inner polybag was merged into the seal of the outer package.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.19X110.0MM)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL.
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10645849
• MDR Text Key: 210409989
• Report Number: 0001811755-2020-02624
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540593368
• UDI-Public: 04546540593368
• 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
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6118119110
• Device Catalogue Number: 6118119110
• Device Lot Number: 20118027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1