MAUDE Adverse Event Report: STRYKER GMBH HOOK/TRIANGLE BLADE KIT; ARTHROSCOPE

Catalog Number	3056-6
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/06/2023
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.
Event or Problem Description
It was reported that the surgeon was using an epf kit.When they pushed q-tip through, there was some black residue on the q-tip.This resulted in the patient having an infection.
Event or Problem Description
It was reported that the surgeon was using an epf kit.When they pushed q-tip through, there was some black residue on the q-tip.This resulted in the patient having an infection.
Additional Manufacturer Narrative
The received pictures were reviewed, the pictures show a dark residue on a cotton swab, the product itself is not visible and therefore it cannot be confirmed that the residue is from the reported hook/triangle blade kit.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation, therefore no further evaluation is possible.A review of the device history for the reported lot did not indicate any abnormalities.The reported lot was released in december 2021 with a lot size of (b)(4) kits and we are not aware of any other complaint of this nature for this lot.The review of the device history has shown that the affected lot did pass a bioburden test, a pyrogen test and a sterility test during the manufacturing process.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.

• Brand Name: HOOK/TRIANGLE BLADE KIT
• Common Device Name: ARTHROSCOPE
• 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: 18041853
• Report Number: 0008031020-2023-00375
• Device Sequence Number: 15328475
• Product Code: HRX
• UDI-Device Identifier: 37613327364171
• UDI-Public: 37613327364171
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K940230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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: Health Professional
• Device Expiration Date: 10/21/2024
• Device Catalogue Number: 3056-6
• Device Lot Number: 236A29421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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: Required Intervention
• Patient Sex: Unknown