MAUDE Adverse Event Report: STRYKER GMBH KIRSCHNER WIRE PINS & WIRES Ø0.8X150MM; PIN, FIXATION, SMOOTH

Catalog Number 390132

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "on (b)(6) 2023, due to trauma, the right forearm internal fixation surgery was performed successfully.15 days after surgery, there was redness, swelling, and purulent exudate in the wound, which was treated with debridement and healed before discharge.".

Manufacturer Narrative

Please note corrections to d1, d2a, d2b, d4 catalog#, d9/h3, g4 510k#, h5, h8.The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidence was provided.The investigation revealed the following: the information provided do belong to non-sterile article.Therefore, it is the user's responsibility to ensure that the products are sterilized according to our specifications.The current instructions for use 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.A review of the device history for the reported lot did not indicate any abnormalities.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.H3 other text : not returned.

Event Description

As reported: "on july 11, 2023, due to trauma, the right forearm internal fixation surgery was performed successfully.15 days after surgery, there was redness, swelling, and purulent exudate in the wound, which was treated with debridement and healed before discharge.".

• Brand Name: KIRSCHNER WIRE PINS & WIRES Ø0.8X150MM
• 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: 18418792
• MDR Text Key: 331603562
• Report Number: 0008031020-2023-00456
• Device Sequence Number: 1
• Product Code: HTY
• 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: Health Professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 02/29/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 390132
• Device Lot Number: 28070H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• 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
• Patient Age: 45 YR
• Patient Sex: Male