MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, STST GAMMA3 10.5X95MM; IMPLANT

Catalog Number 40600095S

Device Problem Positioning Failure (1158)

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

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The customer reported that: "i would like to ask you about a defective 125° short gamma nail.I wanted to insert a short gamma nail this morning for a pertrochanteric fracture.I encountered a problem with the nail locking screw.The cervicocephalic screw was not locking with the proximal locking screw.I mentioned a problem with the cervicocephalic screw.Changing the cervicocephalic screw did not solve the problem.I had to change the 125° short gamma nail, which solved the problem.When testing the nail outside the patient, i found that the locking mechanism of the cervicocephalic screw did not work.I kept the nail in my office in cannes.".

Manufacturer Narrative

The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.The reported event could not be confirmed, since the returned device is fully functional.The device inspection revealed the following: visual inspection: the returned lag screw shows circumferential grooves, densely staggered, beginning at the thread runout of the self-tapping thread, running over the surface and coursing in clockwise and counter-clockwise direction; utmost likely due to contact with the nail during assembling / disassembling in slight oblique mode.Functional inspection: the lag screw could be pushed through the hole for lag screw of the returned trochanteric nail kit, stst gamma3® ø11x180mm x 125°.Therefore, the returned nail and set screw was disassembled.A sample set screw could be inserted into one of the four grooves of the lag screw; the requirements of preventing both rotation and complete migration of the lag screw and sliding in a limited and defined range were fulfilled as intended.The function test performed revealed the lag screw being fully functional; no deviation was found.Dimensional inspection: correct dimensions (with exception of the damaged areas) were confirmed by above mentioned functional check.Additionally, the measure of dimensions was not applicable with regard to the nature of the reported event.Based on the above facts it can be ascertained that the root cause is not related to a deficiency of the device but is rather linked to an inadequate handling by the user.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.

Event Description

The customer [.] reported that: "i would like to ask you about a defective 125° short gamma nail.I wanted to insert a short gamma nail this morning for a pertrochanteric fracture.I encountered a problem with the nail locking screw.The cervicocephalic screw was not locking with the proximal locking screw.I mentioned a problem with the cervicocephalic screw.Changing the cervicocephalic screw did not solve the problem.I had to change the 125° short gamma nail, which solved the problem.When testing the nail outside the patient, i found that the locking mechanism of the cervicocephalic screw did not work.I kept the nail in my office in cannes.".

• Brand Name: LAG SCREW, STST GAMMA3 10.5X95MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11262765
• MDR Text Key: 230753447
• Report Number: 0009610622-2021-00255
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

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 Catalogue Number: 40600095S
• Device Lot Number: K0F207E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1