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

Catalog Number 3056-6

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Unspecified Infection (1930)

Event Date 09/06/2023

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 327020859
• Report Number: 0008031020-2023-00375
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 37613327364171
• UDI-Public: 37613327364171
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 3056-6
• Device Lot Number: 236A29421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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): Required Intervention