MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 HUMERUS Ø4X34 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-4034S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that in the package of article number 18964026s a screw was found that was too long and labelled as a 34mm screw.There were no adverse consequences or clinically significant delay in treatment as a result of the event.The procedure was completed with another screw.
Event or Problem Description
It was reported that in the package of article number 18964026s a screw was found that was too long and labelled as a 34mm screw.There were no adverse consequences or clinically significant delay in treatment as a result of the event.The procedure was completed with another screw.
Additional Manufacturer Narrative
The reported event could not be confirmed since the original packing was not received in which the screw was delivered.The device inspection revealed the following: the received screw was indeed of length 34mm and was found to be in used state, evident by splayed threads at the distal end.Original packing was not received in which the screw was delivered, so the alleged failure could not be confirmed.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.In order to confirm the alleged failure and determine the exact root cause, the original packing must be available for evaluation.However, a device history review was also performed for the other reported screw(catalog 18964026s; lot k08fc8f) of length 26mm.Upon comparing the manufacturing dates of the two respective lots, it was found that they were manufactured 1 month apart, hence a mix-up during manufacturing can be excluded.If any further substantial information is provided, the investigation report will be updated.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 HUMERUS Ø4X34 MM
• 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: kristen canter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12425617
• Report Number: 0009610622-2021-00680
• Device Sequence Number: 4181405
• Product Code: HSB
• UDI-Device Identifier: 04546540202369
• UDI-Public: 04546540202369
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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: 04/30/2026
• Device Model Number: 1896-4034S
• Device Catalogue Number: 18964034S
• Device Lot Number: K0F0E88
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown