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

Model Number 1830-0920S

Device Problem Separation Problem (4043)

Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event 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".

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 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
• Type of Device: 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
• MDR Text Key: 193098336
• Report Number: 0009610622-2020-00134
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540201607
• UDI-Public: 04546540201607
• Combination Product (y/n): N
• PMA/PMN Number: K032523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR