MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE GAMMA3® 300X160MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 13200100

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "the gamma nail surgery took place on (b)(6) 2021.Before the nail was inserted, the surgeon tested the functionality of the targeting device.All holes were continuous, everything fit.By the time the nail was properly seated in the patient, there was already difficulty inserting the femoral neck screw.During distal locking, only the longitudinal hole could be occupied, as the other hole could not be visualized.The radiograph also showed a discrepancy.The insertion handle was reexamined, but no flaws were detectable.Upon further inquiry, it was told that this problem had already occurred several times.Procedure could be completed by freehand locking.".

Manufacturer Narrative

Please note corrections to section h6 (method, results and conclusions codes).The reported event that target device gamma3® was alleged misdrilling could not be confirmed, since the returned device is conforming to specifications and fully functional.Although a real 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.The device inspection revealed the following: the device returned passed the pre-operative function test as intended.Neither a proximal mistargeting nor a distal mistargeting could be confirmed.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 but is not limited by e.G.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.However, according to details provided the procedure was successfully completed ¿by freehand locking¿ which is always an option.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Finally, each device suffers from a long and intensive use and due to the fact that the device has been in use for a longer time [manufactured 2006] it has reached the end of its useful service-life.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

Event Description

As reported: "the gamma nail surgery took place on 10.07.2021.Before the nail was inserted, the surgeon tested the functionality of the targeting device.All holes were continuous, everything fit.By the time the nail was properly seated in the patient, there was already difficulty inserting the femoral neck screw.During distal locking, only the longitudinal hole could be occupied, as the other hole could not be visualized.The radiograph also showed a discrepancy.The insertion handle was reexamined, but no flaws were detectable.Upon further inquiry, it was told that this problem had already occurred several times.Procedure could be completed by freehand locking.".

• Brand Name: TARGET DEVICE GAMMA3® 300X160MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12224191
• MDR Text Key: 263368288
• Report Number: 0009610622-2021-00622
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13200100
• Device Lot Number: KME901486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1