MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADJUSTING DEVICE TIBIA T2 ALPHA TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2353-4105
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "during surgery the adjusting device (2353-4105) can wriggle at the targeting arm (2353-4106).It turns out that a "pin/split" has fallen out of the adjusting device and therefore the feature of "locking" the adjusting device in the targeting arm, is not possible.".
Event or Problem Description
As reported: "during surgery the adjusting device (2353-4105) can wriggle at the targeting arm (2353-4106).It turns out that a "pin/split" has fallen out of the adjusting device and therefore the feature of "locking" the adjusting device in the targeting arm, is not possible.".
Additional Manufacturer Narrative
H4 - manufacture date added; d9 - device return date added.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the returned device confirms the event that the metal cylindric pin could be removed easily without resistance.The pin is not designed to be detachable; without the pin the adjusting device is not locked to the distal targeting arm, so a secure drilling and screw placement was not possible.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.The instructions for use instructs user that: ¿before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.¿ based on investigation, the root cause was attributed to a device-design related issue.The inspection confirmed the reported event: the metal cylindrical pin could be removed easily without resistance.The pin is not designed to be detachable; without the pin the adjusting device is not locked to the distal targeting arm, so a secure drilling and screw placement is not possible.The issue was already addressed by a non-conformity report; the nc investigation showed that the pin can fall of the guide block due to discrepancies in the design (transition fit instead of press fit).Nc is closed and capa is in finalize implementation phase.If any further information is provided, the complaint report will be updated.

• Brand Name: ADJUSTING DEVICE TIBIA T2 ALPHA TIBIA
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11382060
• Report Number: 0009610622-2021-00308
• Device Sequence Number: 4125347
• Product Code: HSB
• UDI-Device Identifier: 07613327357073
• UDI-Public: 07613327357073
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K193308
• 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): 06/02/2021

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: 2353-4105
• Device Catalogue Number: 23534105
• Device Lot Number: KME913779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1