MAUDE Adverse Event Report: STRYKER GMBH L-PLATE, LEFT; PLATE, FIXATION, BONE

Catalog Number	40-15091S
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device discarded by the hospital.
Event or Problem Description
As reported: "the orif was performed for lisfranc injury on (b)(6), 2022.When the l-plate removal on (b)(6) 2024, the surgeon found that the peri-implant tissue became dark.While the removed plate was discarded at the facility.".
Additional Manufacturer Narrative
The received pictures were reviewed and a greyish discoloration of the soft-tissue in the area of the plate can be confirmed.A device inspection was not possible since the affected device was not returned, therefore no further evaluation 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.The complaint was forwarded to rnd for review, with following feedback: "from a rnd perspective this finding is deemed consistent with fretting corrosion; fretting corrosion occurs at the contact points of two metal surfaces that undergo repeated relative motion.In general, wear particles can potentially be generated during clinical use if relative movement between contacting surfaces occurs and the mechanical loads due to contact pressure and friction exceed the surface strength." the complaint was forwarded to medical affairs for review, with following feedback: "this looks like metallosis.Metallosis is a condition caused by the buildup and shedding of metal debris, usually related to ¿rubbing¿ of in this case soft tissues over the plate." the affected devices must be available in order to determine the root cause of the complaint event.Potential causes for metallosis are fretting corrosion, caused by micromovements between plate and screw head, or the generation of an electrical current at the fracture site to due wolff's law.Although very slight, the current occurs within the solutions around the plate and soft tissue and will corrode to metal surface.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the orif was performed for lisfranc injury on (b)(6) 2022.When the l-plate removal on (b)(6) 2024, the surgeon found that the peri-implant tissue became dark.While the removed plate was discarded at the facility.".

• Brand Name: L-PLATE, LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18838099
• Report Number: 0008031020-2024-00113
• Device Sequence Number: 15317945
• Product Code: HRS
• UDI-Device Identifier: 04546540538734
• UDI-Public: 04546540538734
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/03/2024
• Device Catalogue Number: 40-15091S
• Device Lot Number: 1000340309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 40 KG