MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM TIBIA T2 ALPHA? TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23534107
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned, if additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported: "the sleeve retention button on the side of the proximal aiming jig for the t2 alpha tibia cracked and broke while inserting / removing a sleeve." procedure was completed successfully with no adverse consequences or surgical delay reported.
Additional Manufacturer Narrative
The reported event could be confirmed.The returned device confirms the event: a crack could be verified at the grey tightening knob.Investigation determined that a manufacturing agent used at the supplier was leading to cracks in the knob.In order to address this, a nonconformity has been raised.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.No indications of design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "the sleeve retention button on the side of the proximal aiming jig for the t2 alpha tibia cracked and broke while inserting / removing a sleeve." procedure was completed successfully with no adverse consequences or surgical delay reported.

• Brand Name: TARGETING ARM 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
• MDR Report Key: 9153645
• Report Number: 0009610622-2019-00802
• Device Sequence Number: 2626447
• Product Code: HSB
• UDI-Device Identifier: 07613327357080
• UDI-Public: 07613327357080
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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 Catalogue Number: 23534107
• Device Lot Number: KME912431
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1