MAUDE Adverse Event Report: STRYKER GMBH SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #0 / C-2; PIN, FIXATION, SMOOTH

Catalog Number	1910-1272S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "it was reported that an expired implant was used on the patient.Expiration date was 04-may-2024.Discovery was made on 20/may/2024 when attempting to bill for the implant.There was not a delay to the surgery.The surgeon requested the drill and two implants be opened once he confirmed a repair was necessary.I pulled the drill and sonic anchor implants from an implant kit.I confirmed the product descriptions on all three items, and i thought i checked the expiration dates on each before handing them to hospital staff (nurse circulator) to inspect, open, and pass onto the sterile field.The item in question was the third item opened.".
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.
Event or Problem Description
As reported: "it was reported that an expired implant was used on the patient.Expiration date was 04-may-2024.Discovery was made on (b)(6) 2024 when attempting to bill for the implant.There was not a delay to the surgery.The surgeon requested the drill and two implants be opened once he confirmed a repair was necessary.I pulled the drill and sonic anchor implants from an implant kit.I confirmed the product descriptions on all three items, and i thought i checked the expiration dates on each before handing them to hospital staff (nurse circulator) to inspect, open, and pass onto the sterile field.The item in question was the third item opened.".
Additional Manufacturer Narrative
Correction: please refer to section d3.The reported event was not caused by a deficiency of the device as the expiry date was clearly legible on the label and the usage of the implant does not lie in the responsibility of the manufacturer.Review of the device history records of the device reported did not indicate any conspicuities; the dhr contain a copy of the id-label (label for packaging).All labels indicate end of shelf life (b)(6) 2024 (nominal value).The device reported was documented as faultless prior to distribution.Evaluation revealed evidence that the event is not linked to a deficiency of the device but is rather related to off-label use and has to be classified as user-customer-shelf-life exceeded.We have forwarded it in a previous similar case for review and statement by a health care professional [excerpts]: in case of the expiration of shelf-life stryker cannot guarantee the performance and safety for use.Re-sterilization is only possible for those devices where stryker explicitly describes a re-sterilization process in the ifu.The risk of infection will increase with the time passed after the expiry date which is printed on the packaging.Within the labelling there are statements referring to the expiration of shelf life: ¿in the event of contamination, expiration of shelf life, or in the case of products supplied non-sterile, the product must be subjected to an appropriate cleaning process and sterilized by means of a validated sterilization procedure before use, unless specified otherwise in the product labeling or respective product technical guides.¿ a review of the labeling did not indicate any abnormalities.The labelling on the package informs about the expiry date.The ifu instructs among others: ¿please see full labeling for all necessary information!¿ no indications of material, manufacturing or design related problems were found during the investigation.Finally, it lies in the responsibility of the treating surgeon how to proceed further on.At the time of investigation closure no known adverse consequences were reported apart from the fact that an expired implant was implanted.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #0 / C-2
• Common Device Name: PIN, FIXATION, SMOOTH
• 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: 19542027
• Report Number: 0009610622-2024-00286
• Device Sequence Number: 12683033
• Product Code: HTY
• UDI-Device Identifier: 07613327096163
• UDI-Public: 07613327096163
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K143063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2024
• Device Catalogue Number: 1910-1272S
• Device Lot Number: 1000527998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2023
• 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
• Patient Age: 19 YR
• Patient Sex: Female