MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL T2 ALPHA? TIBIA Ø9X315MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2341-0931S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/17/2021
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.Device was discarded by hospital.
Event or Problem Description
It was reported a t2 alpha nail broke just above the most proximal distal locking screw.Was revised the next week to an antibiotic cement nail.
Event or Problem Description
It was reported a t2 alpha nail broke just above the most proximal distal locking screw.Was revised the next week to an antibiotic cement nail.
Additional Manufacturer Narrative
Based on the received x-rays it can be confirmed that the nail is broken at one of the locking holes at the distal end.The affected device was not returned for evaluation, therefore no further investigation is possible.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.No indications of material, manufacturing or design related problems were found during the investigation.Based on the following review of the received information by a medical expert, the root cause was attributed to a patient/injury related issue: [there is no further information given on the patient, except of the gender and age.The first x-ray after the operation shows some interesting findings.There is a 2-level fracture of the tibia visible with one subcondylar fracture and another fracture at the transition between the medial and distal part of the bone.There are several clips visible at the soft tissue, suggesting a severe soft tissue injury in the mid shaft region.Last but not least the patient underwent an arthrodesis of the upper ankle joint earlier.All these findings may have contributed to the non union which finally occurred at the distal fracture.An osteosynthesis at the fibula also could have been considered¿ there seem to be quite a few patient/injury related reasons for the failure of the nail¿] [original statements] if more information is provided, the case will be reassessed.

• Brand Name: TIBIAL NAIL T2 ALPHA? TIBIA Ø9X315MM
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12699093
• Report Number: 0009610622-2021-00767
• Device Sequence Number: 17213803
• Product Code: HSB
• UDI-Device Identifier: 07613327290639
• UDI-Public: 07613327290639
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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 Model Number: 2341-0931S
• Device Catalogue Number: 23410931S
• Device Lot Number: K081476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male