MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SET SCREW, TI GAMMA3® Ø8X17.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30030822S

Device Problems Positioning Failure (1158); Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The gamma 3 femoral neck screw has come loose and has migrated into the pelvis.

Manufacturer Narrative

The reported event could be confirmed.The device inspection revealed the following: the threads of the received set screw was found sheared.The nylstop was also observed with tread marks.Both the observations indicate that there was an insertion of the screw but not an optimal one.The set screw was inserted in an oblique manner and not axial to the nail.A functional inspection of the returned set screw was performed by assembling it with the nail and it was found that the set screw could not advance through the nail due to the deformed threads.However, another functional inspection was performed by assembling the received nail and the lag screw with a sample set screw.Successful locking of lag screw with the set screw was achieved as intended.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation performed, the root cause of the failure is user related.The failure was caused due to a sub-optimal procedure followed by the surgeon and not following the given instructions.The set screw was inserted in an oblique manner as evident by sheared threads.As a result of this the set screw got stuck inside the nail and didn¿t engage with the lag screw.This was confirmed during the device inspection as no bearing mark was observed on any of the grooves of lag screw.Thus the migration of lag screw happened and it moved medially into the pelvis over a period of time.The op-tech provides the following user instructions: ¿push the set screw driver down until you are sure that the set screw engages the corresponding thread in the nail.During pushing down the assembly, you may feel a slight resistance.Turn the screwdriver handle clockwise under continuous pressure.You may notice a resistance when turning the set screw.This is because the set screw thread is equipped with the ¿nylstop¿ system to prevent spontaneous loosening.This is not the final position for the set screw.Keep turning the set screw until you feel contact in one of the grooves of the lag screw.To verify the correct position of the set screw, try to turn the lag screwdriver gently clockwise and counterclockwise.If it is not possible to turn the lag screwdriver, the set screw is engaged in one of the grooves.If the lag screw driver still moves, recorrect the handle position and tighten the set screw again until it engages in one of the four grooves.After slightly tightening the set screw it should then be unscrewed by one quarter (¼) of a turn, until a small play can be felt at the lag screwdriver.This ensures a free sliding of the lag screw.Make sure that the set screw is still engaged in the groove by checking that it is still not possible to turn the lag screw with the lag screwdriver.¿ if any further information is provided, the complaint report will be updated.

Event Description

The gamma 3 femoral neck screw has come loose and has migrated into the pelvis.

• Brand Name: SET SCREW, TI GAMMA3® Ø8X17.5MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 9251852
• MDR Text Key: 164241194
• Report Number: 0009610622-2019-00900
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 30030822S
• Device Lot Number: K0ED0F1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 80