MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 13200111

Device Problem Use of Device Problem (1670)

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

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed, any additional information will be reported in a supplemental report.

Event Description

There is an increasing amount of mis-drilling.Surgical delay of 10min.Not longer.Medical procedure could be completed successfully by doing a distal free-hand-locking.

Manufacturer Narrative

A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.

Event Description

There is an increasing amount of mis-drilling.Surgical delay of 10min.Not longer.Medical procedure could be completed successfully by doing a distal free-hand-locking.

Manufacturer Narrative

The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Although an exact root cause could not be determined the alleged event is most likely caused due to a suboptimal intra-operative procedure and has to be classified as user-customer-user error.Nevertheless, according to event description ¿medical procedure could be completed successfully by doing a distal free-hand-locking.¿ the device inspection revealed the following: a pre-surgical function test was performed on the device returned.The returned target device was assembled with a sample nail and sample instruments.The step drill passed the proximal drill hole of the nail with no contact.The distal drill passed all corresponding distal drill holes in the nail with no contact.The function of the target device was still given.The alleged mis-targeting could not be reproduced.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check it was concluded that the event was mainly based in the intra-operative procedure.Reasons for misaligned drilling are various.Potential miss-targeting can also be caused by: - loosening of the nail holding bolt during insertion of the nail - repeated tightening of the nail holding screw prior to distal targeting / drilling is recommended - not realized unintended loosening of the attachment knob (will lead to release of the drill sleeve) - no use of drill with centre tip / unfavourable bone contour - drilling without drill guiding sleeve - using blunt or damaged drill - high forces applied to the target device during drilling eventually leading to unintended distortion in the system of drill, sleeve, target device and nail this is the first reported case with this lot number, the device can be therefore confirmed faultless prior the distribution.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

Event Description

There is an increasing amount of mis-drilling.Surgical delay of 10min.Not longer.Medical procedure could be completed successfully by doing a distal free-hand-locking.

• Brand Name: TARGET DEVICE GAMMA3®
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8492733
• MDR Text Key: 141792853
• Report Number: 0009610622-2019-00153
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (y/n): N
• PMA/PMN Number: K123401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200111
• Device Lot Number: KME910545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other