MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW T2 ANKLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-3203
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.The device was missing, no device to evaluate.
Event or Problem Description
The following was reported: an ankle arthrodesis with the t2 sga nail was to take place.When the sales rep arrived, he was informed that the loaner instruments had not been delivered in complete form.The patient was already anesthetized and the surgery had already begun.The sales rep's internal clinic investigation revealed that two essential components (item# 18063211 and item# 18063203) had not been supplied.The sales rep was asked which hospital nearby had the system permanently installed.The devices were requested from the nearby hospital.They were delivered, and the surgery was completed.There was a 60-minute surgical delay due to this issue.As a result, the anesthesia had to be prolonged.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿do not use components of stryker product systems together with components from any other manufacturer unless specified otherwise in the operative technique.Before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other¿ 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.However, a local nc has been raised to investigate this issue and prevent such failures.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The following was reported: an ankle arthrodesis with the t2 sga nail was to take place.When the sales rep arrived, he was informed that the loaner instruments had not been delivered in complete form.The patient was already anesthetized and the surgery had already begun.The sales rep's internal clinic investigation revealed that two essential components (item# 18063211 and item# 18063203) had not been supplied.The sales rep was asked which hospital nearby had the system permanently installed.The devices were requested from the nearby hospital.They were delivered, and the surgery was completed.There was a 60-minute surgical delay due to this issue; as a result, the anesthesia had to be prolonged.

• Brand Name: NAIL HOLDING SCREW T2 ANKLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11982943
• Report Number: 0009610622-2021-00556
• Device Sequence Number: 3237377
• Product Code: LXH
• UDI-Device Identifier: 04546540708458
• UDI-Public: 04546540708458
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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 Model Number: 1806-3203
• Device Catalogue Number: 18063203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1