MAUDE Adverse Event Report: STRYKER TRAUMA KIEL HUMERAL NAIL T2 HUMERUS 9X200 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1830-0920S
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348)
Date of Event	03/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.
Event or Problem Description
As reported: "proximal screw back out.No replacement device used, only the screw was removed." additionally reported: "patient reported pain and x-ray shown indicated screw back out".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and according to x-ray images available it is still implanted.Finally, according to details provided under the event description ¿no replacement device used, only the screw was removed¿ and no other evidence was provided.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.Therefore, from technical point of view a statement is impossible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.However, provided x-ray images were forwarded to our hcp for a medical statement ¿ his comments [excerpts]: ¿¿looks like something we would have called norif.No reduction internal fixation.The fracture is fixed in the post-traumatic deformity.Maybe the loosening of the screw contributed to it.But overall, the fracture is not adequately addressed with this nailing.Either reduce the fracture better and use the existing screw holes to stabilize or fix it with a plate.¿ the file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.
Event or Problem Description
As reported: "proximal screw back out.No replacement device used, only the screw was removed." additionally reported: "patient reported pain and x-ray shown indicated screw back out.

• Brand Name: HUMERAL NAIL T2 HUMERUS 9X200 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; DE D-24232
• MDR Report Key: 9907827
• Report Number: 0009610622-2020-00134
• Device Sequence Number: 16829709
• Product Code: HSB
• UDI-Device Identifier: 04546540201607
• UDI-Public: 04546540201607
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Model Number: 1830-0920S
• Device Catalogue Number: 18300920S
• Device Lot Number: K277386RB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR