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

Model Number 1910-1272S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 01/01/2020

Event Type  Injury  

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 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.".

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 iso10993-1:2009 [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.

Event 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.".

• Brand Name: SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #0 / C-2
• Type of Device: 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: 12413465
• MDR Text Key: 269520045
• Report Number: 0008031020-2021-00397
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613327096163
• UDI-Public: 07613327096163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/01/2020
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female