MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE 12X200MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1819-1220S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported the devices 1891-5050s and 1986-5050s were broken due to non-union, but were successfully removed along with other retained hardware.Revision with hoffmann lrf external fixation.
Event or Problem Description
It was reported the devices 1891-5050s and 1986-5050s were broken due to non-union, but were successfully removed along with other retained hardware.Revision with hoffmann lrf external fixation.
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 device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: ANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE 12X200MM
• 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: 12333015
• Report Number: 0009610622-2021-00641
• Device Sequence Number: 4712962
• Product Code: HSB
• UDI-Device Identifier: 04546540673442
• UDI-Public: 04546540673442
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 09/30/2023
• Device Model Number: 1819-1220S
• Device Catalogue Number: 18191220S
• Device Lot Number: K080A97
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 10/25/2021
• 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