MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 35200280S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During gamma3 surgery, the set screw was inserted to the soft tissue by the technical error of the surgeon.The set screw did not removed from the patient, the lag screw was locked with the second set screw.

Manufacturer Narrative

Catalog number, lot number, 510k number.In the case presented, ¿during gamma3 surgery, the set screw was inserted to the soft tissue by the technical error of the surgeon.The set screw did not removed from the patient, the lag screw was locked with the second set screw¿.A physical examination could not be carried out as the device was not returned for evaluation.No deviations were found during review of the manufacturing documents (dhr).The device was documented as faultless prior to distribution.Based on the additional information received, the set screwdriver was not defective and the self-holding c-ring was also not detached.The available information provided were presented to consulting expert and clinical statement was provided as follows: ¿no adverse effects could be expected because of the left set screw in the soft tissue, usually the lost screw will remain in the surrounding soft tissue without further consequence for the patient.In contrast to k-wires, who have a tendency of spontaneous migration and may cause severe complications (there are cases described with migration from the forearm to the heart with fatal perforation), a screw having a thread will remain where it is.The biocompatibility of the set screw is proven and will not cause any tissue reactions.¿ according to the labelling review, sufficient guidelines are provided in the operative technique related to the set screw positioning, insertion & fixation.Every single step is described in detail.As already stated in the ifu, doctors and or staff should ensure that they are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.According to the information received in the pi ¿the set screw was inserted to the soft tissue by the technical error of the surgeon.The surgeon did not insert the set screw carefully.Then the set screw was inserted to the soft tissue.¿ based on the above observations the root cause of the reported event is not linked to a deficiency of the device, but is rather considered user related (user-customer-application errors; person makes a mistake, slip / (op-staff related event).As neither the item nor further information such as x-rays were provided, the reported event could not be confirmed.Review of complaint history, capa databases, risk analysis and the labelling did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no open actions in place related to the reported event for the subject product.No non-conformity was identified.

Event Description

During gamma3 surgery, the set screw was inserted to the soft tissue by the technical error of the surgeon.The set screw did not removed from the patient, the lag screw was locked with the second set screw.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM X 120°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 6629288
• MDR Text Key: 77434408
• Report Number: 0009610622-2017-00184
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 35200280S
• Device Lot Number: K0B8515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 10/05/2017
• Supplement Dates FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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