MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 CANNULA; INSTRUMENT

Catalog Number UNK_KIE

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

Patient Problem No Code Available (3191)

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.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.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, possible cause of failure could be attributed to user related issue.Screw head was not able to pass through, because surgeon tried inserting the locking screw, without removing drill sleeve from the tissue protection sleeve.If device is returned or any further information is provided, the investigation report will be reassessed.

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 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: UNKNOWN T2 CANNULA
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8406011
• MDR Text Key: 138772075
• Report Number: 0009610622-2019-00103
• Device Sequence Number: 0
• Product Code: LXH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other