MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM TNS T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061001
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
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
The customer reported that they put the drill through the jig and into the nail and that the jig had too much play in it which caused the drill to snap off in the patient and nail.It was deemed to difficult to get the piece out so the surgeon left it in situ.Unintended metal in the patient.
Additional Manufacturer Narrative
Correction: section d4 (lot #).The reported event could be confirmed, since play of less than 0.5mm was observed at implant positioning location on targeting device.This instrument batch was released in 2014, meaning approximately 5 years of likely successful repeated use.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inadequate inspection of device functionality before and during surgical procedure.The device inspection revealed the following: visual inspection: did not reveal physical damage to device, only patterns associated with normal wear.Functional inspection was carried out in comparison to an alternate nail holding screw and targeting device.Play of less than 0.5mm was observed at the reported targeting device.Positioning screws were adjusted and play was no longer observed.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.Ifu states: ¿ensure that you are familiar with the intended uses, compatibility and correct handling of the instrument, which are described in the operative technique of the product system.Please remember that product systems may be subject to alterations that may affect the compatibility of the instrument with other instruments or with implants.For your information, avail yourself of the training courses and publications offered." ¿ before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.During the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure." no indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reported that they put the drill through the jig and into the nail and that the jig had too much play in it which caused the drill to snap off in the patient and nail.It was deemed to difficult to get the piece out so the surgeon left it in situ.Unintended metal in the patient.

• Brand Name: TARGETING ARM TNS T2 TIBIA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8935581
• Report Number: 0009610622-2019-00627
• Device Sequence Number: 2520876
• Product Code: LXH
• UDI-Device Identifier: 04546540196521
• UDI-Public: 04546540196521
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 10/23/2019

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: 18061001
• Device Lot Number: KHI142105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1