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

Model Number	1826-1036S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was implanted.
Event or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2020-00409
• Device Sequence Number: 3083767
• Product Code: HSB
• UDI-Device Identifier: 04546540378859
• UDI-Public: 04546540378859
• Combination Product (Y/N): N
• PMA/510(K) Number: K023267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1