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

Device Problem Device Damaged by Another Device (2915)

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

Event Date 03/16/2020

Event Type  malfunction  

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 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".

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 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
• Type of Device: 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
• MDR Text Key: 191569864
• Report Number: 0009610622-2020-00145
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540195890
• UDI-Public: 04546540195890
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1806-0080S
• Device Catalogue Number: 18060080S
• Device Lot Number: K083C75
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1