MAUDE Adverse Event Report: STRYKER GMBH LARGE ROCKER SHOE - LONG HOFFMANN LRF 180MM - 210MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49348180
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Failure of Implant (1924); Ambulation or Postural Difficulties (2544)
Date of Event	01/18/2024
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
As reported: "surgery took place successfully on (b)(6) 2023, patient came for a check-up and the defect was discovered.Patient is currently not able to put optimal weight on the leg and step on it due to the damage to the product.".
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received product shows that one of the large rocker shoe has a loos sole.Furthermore, it¿s visible the part is damage from use (red marking), as the rocker shoe shaft shows deformation and the black color chipped.In addition, the traces of glue are visible between the sole and the rocker show shaft.Quality assurance engineering reviewed the received information and noted: all inspection specifications were complied with, all parts of this lot correspond to the specifications.In accordance with the inspection specifications, a 100% adhesion test (adhesive bond) was carried out and was documented and completed as fulfilled.Two anomalies were observed during the examination: 1.Visible glue residue on the entire sole and the base support, which leads to the conclusion that the sole was glued.2.A visible impact was found on the sole, which presumably led to the sole having come loose with the base support.In conclusion, it can be assumed that the use of this rocker shoe has resulted in one or more impacts (hit) and that the adhesive bond has been damaged and the sole has fallen off.There are also visible signs of wear on the entire rocker shoe, which is a further indication that the rocker shoe has been subjected to greater forces.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.What can be mentioned is that the item was manufactured for single use.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a use related issue.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "surgery took place successfully on (b)(6) 2023, patient came for a check-up and the defect was discovered.Patient is currently not able to put optimal weight on the leg and step on it due to the damage to the product.".

• Brand Name: LARGE ROCKER SHOE - LONG HOFFMANN LRF 180MM - 210MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18712747
• Report Number: 0008031020-2024-00104
• Device Sequence Number: 15495177
• Product Code: KTT
• UDI-Device Identifier: 07613252592020
• UDI-Public: 07613252592020
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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 Catalogue Number: 49348180
• Device Lot Number: K72711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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: Other
• Patient Sex: Unknown