MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (18.0X0.97X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number 6118097090

Device Problems Delivered as Unsterile Product (1421); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during incoming inspection, the customer noticed foreign material inside the 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

B5: following inspection of the returned device, this is not a reportable event.H6: the quality investigation is complete.

Event Description

It was reported that during incoming inspection, the customer noticed foreign material inside the 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.It was subsequently confirmed that there was no impact to the sterility of the package following inspection of the returned device.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (18.0X0.97X90MM)
• 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: 10178554
• MDR Text Key: 195918544
• Report Number: 0001811755-2020-01522
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540501394
• UDI-Public: 04546540501394
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2024
• Device Model Number: 6118097090
• Device Catalogue Number: 6118097090
• Device Lot Number: 19124017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1