MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 31250170S

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 04/03/2015

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2015, the patient underwent the surgery with g3 nail.After surgery, when the operating room staff checked the devices, the set screw was found in the nail holding screw.Therefore, the surgeon confirmed x-ray.And he found that the set screw isn't inserted in nail.The patient underwent the revision surgery (the set screw was inserted in nail) on (b)(6) 2015.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation summary: the evaluation revealed the nail kit to be the primary product; the set screw is part of the nail kit.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail kit was documented as faultless prior to distribution.An investigation was not possible because the products were not provided, the root cause of the set screw insertion difficulties could not be determined.The customer reported that the set screw was found within the nail holding screw (nhs); furthermore the set screw was successfully implanted into the nail in a revision surgery.It can be assumed that the implants worked like specified and were fully functional.Also the nhs was found ¿normal¿; therefore it can be also assumed that the nhs was fully functional.Based on this information the case must be caused by an intra-operative user error; it is conceivable that the set screw was pushed in oblique mode through the nail holding screw and got jammed.This jamming was most likely caused by not using a flexible screwdriver.At this time the surgeon should register that the set screw is not inserted deeply enough; the lag screw shall be slightly rotated to identify whether the set screw has reached one of the lag screw flutes.Because the initial surgery was finished without the set screw it can be assumed that the surgeon ignored this critical surgery step.The set screw placement is not an option! the set screw prevents the lag screw against migration and rotation.No discrepancies were detected during risk analysis review.No non-conformity identified; no actions are in place.Device was never received.

Event Description

It was reported that on (b)(6) 2015, the patient underwent the surgery with g3 nail.After surgery, when the operating room staff checked the devices, the set screw was found in the nail holding screw.Therefore, the surgeon confirmed x-ray.And he found that the set screw isn't inserted in nail.The patient underwent the revision surgery (the set screw was inserted in nail) on (b)(6) 2015.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4746040
• MDR Text Key: 5825505
• Report Number: 0009610622-2015-00226
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 31250170S
• Device Lot Number: K045FD9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 05/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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): Required Intervention
• Patient Age: 90 YR