MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, STST GAMMA3® Ø10.5X100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 40600100S

Device Problem Positioning Failure (1158)

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

Event Date 04/15/2022

Event Type  malfunction  

Event Description

The customer reported that : "during the installation, the kirchner wire was well in place, the auger passed normally but we were not able to install the cervical screw which greatly delayed the operation.The surgeon took the nail out again for an external check and we could see that the cervical screw was rubbing on the nail.We repositioned the nail and changed the cervical screw with a different lot number and were able to complete the procedure normally.An echographie was performed.".

Manufacturer Narrative

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

Event Description

The customer reported that : "during the installation, the kirchner wire was well in place, the auger passed normally but we were not able to install the cervical screw which greatly delayed the operation.The surgeon took the nail out again for an external check and we could see that the cervical screw was rubbing on the nail.We repositioned the nail and changed the cervical screw with a different lot number and were able to complete the procedure normally.An echographie was performed ".

Manufacturer Narrative

The reported event could not be confirmed, since the returned device is conforming to specifications and is fully functional.The device inspection revealed the following: the catalog number and the lot number marked could not be identified due to the wear marks on the device, making them illegible.The visual inspection has shown that the device is slightly damaged.Usage marks can be seen on the screw, these signs of wear could indicate that the insertion of the screw into the nail was forced and was not performed as intended.It is possible that the screw was not fully aligned with the nail's proximal hole when the insertion was performed.The forced and misaligned insertion may have caused material seizing which increased the diameter of the lag screw just before the bone thread.During the functional inspection, the lag screw was tested with a gamma 3 nail.The lag screw could be inserted and fits into the nail without any issue.Therefore, this device could be considered as fully functional.Based on the investigation, the root cause was attributed to an user related issue.The lag screw may not have been inserted as intended and was not aligned with the nail's proximal hole as advised.As a reminder, the operative technique clearly states that: " before starting surgery, the implant and instrument assembly must be checked.Ensure that the sleeve angle matches the corresponding nail angle chosen, e.G., a 125° position in speedlock sleeve for a 125° nail.[¿] lag screw positioning using the one shot device the one shot device is recommended for establishing whether the lag screw is in the optimum position.This device is designed to enable correct positioning of the k-wire for lag screw placement before performing lateral skin incision and opening of the lateral cortex.¿ the diameter of the lag screw just before the thread is above specification (10.527 mm).However, this is most likely due to the failed insertion, which may have led to material seizing, increasing the diameter of this part of the device.The diameter of the other parts of the lag screw is according to specification, therefore it is unlikely that this increased diameter is related to a manufacturing error.It has to be noted that although the diameter of the lag screw was increased, it passed the proximal drill hole of the sample nail.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.If more information is provided, the case will be reassessed.

• Brand Name: LAG SCREW, STST GAMMA3® Ø10.5X100MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14340158
• MDR Text Key: 291866654
• Report Number: 0009610622-2022-00176
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 40600100S
• Device Lot Number: K0CB43A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• 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