MAUDE Adverse Event Report: STRYKER GMBH GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X1250 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-1250S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
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
As reported: "primary procedure, right side gamma nail.After operation was complete and the branch tried to bill the order, a disposable opened for the case was unable to be billed because it was expired.Discovery was made 12 days post op.The disposable came into contact with another instrument but did not come into contact with the patient.Surgery was completed successfully with no delay.Guide wire expired 28-feb-2023".
Additional Manufacturer Narrative
Please note the correction to d3.The reported event could be confirmed, since as per the device label and information, it expired on 28th february 2023 while the surgery happened on (b)(6) 2023.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Information regarding the device, including its expiration date is clearly available on its packaging.Therefore, it is the responsibility of the operating surgeon and the staff to check that before the surgery.This is required as per ifu.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "primary procedure, right side gamma nail.After operation was complete and the branch tried to bill the order, a disposable opened for the case was unable to be billed because it was expired.Discovery was made 12 days post op.The disposable came into contact with another instrument but did not come into contact with the patient.Surgery was completed successfully with no delay.Guide wire expired 28-feb-2023".

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X1250 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16717898
• Report Number: 0009610622-2023-00112
• Device Sequence Number: 7274950
• Product Code: LXH
• UDI-Device Identifier: 07613153311911
• UDI-Public: 07613153311911
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1806-1250S
• Device Catalogue Number: 18061250S
• Device Lot Number: K06CDE9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2018
• 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
• Patient Age: 28 YR
• Patient Sex: Male