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

Catalog Number 18060083S

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

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

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event 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
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8405949
• MDR Text Key: 139326682
• Report Number: 0009610622-2019-00101
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540195913
• UDI-Public: 04546540195913
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 18060083S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other