MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X80MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30660080S

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "it was reported that, during a surgery, when a nurse opened the blister package, a surgeon noticed a foreign material in the package.A spare was used instead." procedure was completed successfully with no adverse consequences or surgical delay reported.

Manufacturer Narrative

The reported event could be confirmed.Based on investigation, the root cause was attributed to be manufacturing related.A non-conformity report had been opened in order to further investigate and address this issue for further details.If any further information is provided, the investigation report will be updated.

Event Description

As reported: "it was reported that, during a surgery, when a nurse opened the blister package, a surgeon noticed a foreign material in the package.A spare was used instead." procedure was completed successfully with no adverse consequences or surgical delay reported.

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X80MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 9153699
• MDR Text Key: 191973124
• Report Number: 0009610622-2019-00803
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540595966
• UDI-Public: 04546540595966
• Combination Product (y/n): N
• PMA/PMN Number: K043431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

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: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 30660080S
• Device Lot Number: 0A326F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1