MAUDE Adverse Event Report: STRYKER GMBH KIRSCHNER WIRE Ø1.0X150MM; PIN, FIXATION, SMOOTH

Model Number 5018-6-150

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 10/31/2022

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.H3 other text : device disposition is unknown.

Event Description

As reported: the surgery was completed on (b)(6) 2022, due to left thumb fracture.Postoperative infection was observed on (b)(6) 2022.Debridement vsd negative pressure suction surgery has been finished.".

Event Description

As reported: the surgery was completed on (b)(6) 2022 due to left thumb fracture.Postoperative infection was observed on (b)(6) 2022.Debridement vsd negative pressure suction surgery has been finished.".

Manufacturer Narrative

The complaint couldn't be confirmed, since the information for evaluation does not match the alleged failure.The device inspection revealed the following: a device inspection was not possible since the affected device was not returned for investigation.An inspection of the image has shown that three wires can be located two at thumb and one at ring finger.Furthermore, within all wires, the distal end looks out of the finger.No further statement is possible to the received image.The current instructions for cleaning, sterilization, inspection and maintenance state: "in the event of contamination, or expiration of shelf life or in the case of a medical device supplied non-sterile, the medical device 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 ifu.If a sterile medical device is also sold nonsterile, the sterile medical device can be put into the dedicated labeled location of the non-sterile medical device in the tray and then be sterilized by means of a validated sterilization procedure before use." a review of the device history for the reported lot did not indicate any abnormalities.The article met all the criteria when it was released non-sterile.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 must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: KIRSCHNER WIRE Ø1.0X150MM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 16935852
• MDR Text Key: 315270479
• Report Number: 0008031020-2023-00189
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 37613327072489
• UDI-Public: 37613327072489
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5018-6-150
• Device Catalogue Number: 390142
• Device Lot Number: 23860H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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