MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE Ø11X150MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1819-1115S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	11/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that a t2 ankle nail snapped inside a patient in an uncommon spot while she was just walking.The break resulted in a revision surgery and caused significant pain.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: only the distal fragment of the nail was returned.The nail had broken in the webs of the oblong drill hole at distal.The breakage surface showed evidences of a fatigue fracture like lines of rest and missing plastic deformation.With the help of a microscope a secondary fracture could be identified close to the breakage edge of the web.Scuffed off coating resp.Non scuffed off coating inside the drill holes for the locking screw identified not all drill holes had been occupied.Otherwise no deficiencies determined.Dimensional inspection indicates that the device is within the specifications.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.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.In the case presented a 66-year-old female patient, no other data available, had been treated with above implant on (b)(6) 2021 due to not named reasons.On (b)(6) 2022, 18 months post initial treatment, the implant was revised due to breakage.Medical records were and / or op-reports were not made available.With given information it could not be determined if the bone had healed, it could not be determined if the patient had been compliant.The question of weight bearing in general could not be cleared, either.The breakage pattern on the item returned showed a fatigue fracture indicated by lines of rest, missing plastic deformation and a secondary crack.The general appearance of the breakage surfaces lead to to the conclusion that implant had been highly loaded.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that a t2 ankle nail snapped inside a patient in an uncommon spot while she was just walking.The break resulted in a revision surgery and caused significant pain.

• Brand Name: ANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE Ø11X150MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15975510
• Report Number: 0009610622-2022-00580
• Device Sequence Number: 12502559
• Product Code: HSB
• UDI-Device Identifier: 04546540673404
• UDI-Public: 04546540673404
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K051590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 12/31/2025
• Device Model Number: 1819-1115S
• Device Catalogue Number: 18191115S
• Device Lot Number: KOB74E1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2022
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female