MAUDE Adverse Event Report: STRYKER GMBH END CAP TIBIA T2 ALPHA TIBIA Ø11.5, +10MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 23410010S

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported: "the head of the end cap slipped during removal, causing removal difficulty.The end cap was locked tightly and the tip of the screwdriver was deformed.The reverse threaded screwdriver of the removal instrument was also broken.Other instruments used were also damaged.Finally the end cap and other implants were removed from the patient.".

Manufacturer Narrative

Please note corrections to section d9/h3, the device was not returned for inspection.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences in relation to the tightly locked end cap were provided.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 as well as the affected device 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 : device disposition is unknown.

Event Description

As reported: "the head of the end cap slipped during removal, causing removal difficulty.The end cap was locked tightly and the tip of the screwdriver was deformed.The reverse threaded screwdriver of the removal instrument was also broken.Other instruments used were also damaged.Finally the end cap and other implants were removed from the patient.".

• Brand Name: END CAP TIBIA T2 ALPHA TIBIA Ø11.5, +10MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 18425683
• MDR Text Key: 331923077
• Report Number: 0009610622-2024-00005
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327365030
• UDI-Public: 07613327365030
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23410010S
• Device Lot Number: K07F1AD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 90 KG