MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060083S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
During primary procedure of left humerus.It was reported that when reaming, the reamers (size 6-8 in.5mm increments) were difficult to advance over the 3.0 800mm guide wire.Surgeon reamed to size 8 and moved to modular reamers to more easily ream.After the nail was placed with the targeter, a screw hole was drilled using the cannula.After drilling, he inserted the first screw and the cannula became stuck on the screw head and was difficult to remove.Then the second proximal screw hole was drilled.As the surgeon advanced the screw down the cannula, he thought the screw head was going to become stuck again.Surgeon removed the cannula to attempt to implant the screw, could not find the drilled hole, and had to make an incision to remove the screw.Surgery was completed with an overall delay of approximately 20 minutes.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 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: 8405949
• Report Number: 0009610622-2019-00101
• Device Sequence Number: 277485
• Product Code: LXH
• UDI-Device Identifier: 04546540195913
• UDI-Public: 04546540195913
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 03/08/2019

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: 18060083S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/08/2019
• 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