MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	1806-0080S
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
The customer reported that : "the guide rod is damaged by the reamer during the operation on the tibial shaft , the guide rod n1 then n2 were altered by the reamer, or possible defect not visible to the naked eye nor to the operating team's touch.Consequences: metal debris on reamers, rod change, broken reamer".
Additional Manufacturer Narrative
The reported event that guide wire, ball-tipped, sterile t2 tibia ø3x800 mm was alleged of issue ¿instrument - deformation during implantation¿ could not be confirmed, since the device was not returned for evaluation and no other evidences 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.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.However, based on risk management file some of the possible causes of this failure are but not limited to: strong bent in wire tip, cannulation clogged etc.The instruction for use recommends to continuously check the position of k wire tip with an image intensifier during insertion.It also recommends use of fluoroscopy whenever cannulated instruments are advanced over a k-wire and to always treat the instrument carefully to avoid surface damage or alterations to the geometry.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that : "the guide rod is damaged by the reamer during the operation on the tibial shaft , the guide rod n1 then n2 were altered by the reamer, or possible defect not visible to the naked eye nor to the operating team's touch.Consequences: metal debris on reamers, rod change, broken reamer.".

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9954992
• Report Number: 0009610622-2020-00145
• Device Sequence Number: 2817464
• Product Code: LPH
• UDI-Device Identifier: 04546540195890
• UDI-Public: 04546540195890
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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 Expiration Date: 11/30/2024
• Device Model Number: 1806-0080S
• Device Catalogue Number: 18060080S
• Device Lot Number: K083C75
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1