MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0085S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The pharmacist at the clinic, reported the following event to the sales rep : "rupture of the guide wire ref (b)(4) into the reamer shaft diam 8.The guide could not slide and finally fractured into the shaft.Is it a wear fail doctor indicated that the event occured during a tibial nailing.There was a delay in the procedure, increase of the infection risk and peroperative fracture.It was necessary to change the guide and to reduce the fracture again.
Event or Problem Description
The pharmacist at the clinic, reported the following event to the sales rep : "rupture of the guide wire ref (b)(4) into the reamer shaft diam 8.The guide could not slide and finally fractured into the shaft.Is it a wear fail.Doctor indicated that the event occured during a tibial nailing.There was a delay in the procedure, increase of the infection risk and peroperative fracture.It was necessary to change the guide and to reduce the fracture again.
Additional Manufacturer Narrative
The reported event that guide wire, ball-tipped, sterile t2 femur ø3x1000 mm was alleged of issue (instruments - guide wire - broken) could not be confirmed, however returned device could be confirmed for issue (instruments - guide wire ¿ deformed), since the returned device is bend.The device inspection revealed the following: visual inspection: guide wire, ball-tipped, sterile t2 femur ø3x1000 mm was found to be bent not broken.Scratches were visible on guide wire tip.The damage pattern indicates that the guide wire was deformed due to insertion into the marrow channel or it was pre-deformed by the user.Most likely the patient had a hard bone structure.Functional inspection: functional test was performed with a sample guide wire (ø 3 mm).It was not possible to move the guide wire through the both segments of broken reamer.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by failure to mishandling / failure to proper handling of the guide wire by the user.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.The instruction for use advises users that ¿ensure that you are familiar with the intended uses, compatibility and correct handling of the instrument.Only use the instrument for its intended purpose as described in the operative technique for the product system.¿ if any additional information is provided, the investigation will be reassessed.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM
• 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: 7481133
• Report Number: 0009610622-2018-00197
• Device Sequence Number: 1963280
• Product Code: LXH
• UDI-Device Identifier: 04546540195937
• UDI-Public: (01)04546540195937
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: 01/31/2023
• Device Model Number: 1806-0085S
• Device Catalogue Number: 18060085S
• Device Lot Number: K0E4813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other