MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SUPRACONDYLAR NAIL T2 SCN 10X360MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1826-1036S

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was implanted.

Event Description

As reported: "styrofoam scrapes was in the nail screw holes in a sterile package when the package of the nail was opened during the operation.The procedure continued without exchanging the product after it was cleaned.".

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿inspection is recommended prior to surgery to determine if instruments or implants have been damaged during storage or prior procedures.'¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

As reported: "styrofoam scrapes was in the nail screw holes in a sterile package when the package of the nail was opened during the operation.The procedure continued without exchanging the product after it was cleaned.".

• Brand Name: SUPRACONDYLAR NAIL T2 SCN 10X360MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10339752
• MDR Text Key: 200852146
• Report Number: 0009610622-2020-00409
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540378859
• UDI-Public: 04546540378859
• Combination Product (y/n): N
• PMA/PMN Number: K023267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 1826-1036S
• Device Catalogue Number: 18261036S
• Device Lot Number: K0AABC6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1