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

Model Number	1910-1272S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	01/01/2020
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.Implant was a bioabsorbable that left behind the patient's own bone marrow edema.
Event or Problem Description
It was reported: "the patient slowly developed a reaction at the implant site (fibula) resulting in pain and swelling after an atf primary repair.Implant was a bioabsorbable that left behind the patient's own bone marrow edema.".
Event or Problem Description
It was reported: "the patient slowly developed a reaction at the implant site (fibula) resulting in pain and swelling after an atf primary repair.Implant was a bioabsorbable that left behind the patient's own bone marrow edema.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A review of the device history for the reported lot did not indicate any abnormalities.In particular sterilization steps and the irradiation protocol were checked in detail and no deviations verified and thus, we exclude a manufacturing error.No corrective actions are required at this time.During screening study on cytotoxicity to address (b)(6)[1] and fda`s blue book memorandum, tests were performed and according to summary [excerpts] ¿¿existing data regarding the biocompatibility of the sonicanchor 3 year acc.Aged were summarized¿the biological and chemical patient risks were assessed based on the existing data.The cytotoxicity test of the sonicanchor resulted in no cytotoxic effects.Therefore, the requirements acc.Iso 10993-1 [1] are fulfilled in terms of cytotoxicity.¿ received information were forwarded to an hcp for a medical statement and according to him [excerpts]: ¿¿bioresorbable products sometimes take a very long time to dissolve completely.Even self-dissolving sutures are sometimes found after many months.And dissolution itself naturally leads to a prolonged, i.E., greatly prolonged reaction, or exposure to foreign materials, and thus places higher demands on biocompatibility than a product that does not dissolve and (at least in our opinion) then becomes largely biologically inactive.¿ a more detailed clinical statement is not possible on the info currently given.Furthermore, whether an allergy test was performed was requested but to no avail.However, material sensitivity reactions are clearly pointed out as adverse effects under the corresponding labelling.Finally, due to information available an exact root cause could not be determined but it could not be excluded that the reported event is rather clinical than device related.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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12413622
• Report Number: 0008031020-2021-00398
• Device Sequence Number: 17078317
• Product Code: HTY
• UDI-Device Identifier: 07613327096163
• UDI-Public: 07613327096163
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K143063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/06/2018
• Device Model Number: 1910-1272S
• Device Catalogue Number: 1910-1272S
• Device Lot Number: 1000287745
• 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: 01/01/2020
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female