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

Catalog Number 23534107

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Company representative reported the following: "after a surgery was successfully completed, i was putting the instruments back into the tray and noticed the grey knob to lock the targeting arm to the nail adaptor was cracked.".

Manufacturer Narrative

Correction: section d4 (lot #).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 Description

Company representative reported the following: "after a surgery was successfully completed, i was putting the instruments back into the tray and noticed the grey knob to lock the targeting arm to the nail adaptor was cracked.".

• Brand Name: TARGETING ARM TIBIA T2 ALPHA? TIBIA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8858054
• MDR Text Key: 153804004
• Report Number: 0009610622-2019-00602
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327357080
• UDI-Public: 07613327357080
• Combination Product (y/n): N
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23534107
• Device Lot Number: KME912402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1