MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 4.0MM / L30MM; PLATE, FIXATION, BONE

Catalog Number 371530

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The locking screw (lot j08386) can¿t insert into pin hole during medical surgery.And then, the doctor tried to insert another two locking screws (lot j01439) into pin hole again on the outside of body.The locking screws always have issue to implant.Finally, the doctor used cortex screw instead of locking screw to finished surgery.

Manufacturer Narrative

The event could be confirmed, since the devices were returned for evaluation and they match the reported failure modes.The reported ¿locking screw axsos 4.0mm / l30mm¿ was received for inspection intact.The head of the screw and the hexagon have scratched surfaces, while the threads, just below the head, are deformed.A functional inspection ¿ inserting the reported screw in the holes of a compatible plate ¿ was performed and it was identified that the screw cannot be locked in the plate.The inspection protocol was reviewed and did not indicate any deviations from the specifications.Therefore the reported ¿locking screw axsos 4.0mm / l30mm¿ was not delivered deformed, but became like that upon usage.It was reported that the screws were inserted manually after the drilling of the holes, no power tool was used, no torque limiter was used for the final insertion, and axial pressure was applied.Also, since the screws did not advance, the customer tried to push and turn them two times from different angles.A deviation from the instructions for proper usage could have definitely led to a deformation of the device and the reported no-locking event.Please keep in mind that the instructions for proper use of the devices should be followed at all times.Consequently, the devices experienced an improper handling which led to the reported malfunction.Based on the investigation, the root cause was attributed to a user related issue.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 any further information is provided, the investigation report will be updated.

Event Description

The locking screw (lot j08386) can¿t insert into pin hole during medical surgery.And then, the doctor tried to insert another two locking screws (lot j01439) into pin hole again on the outside of body.The locking screws always have issue to implant.Finally, the doctor used cortex screw instead of locking screw to finished surgery.

• Brand Name: LOCKING SCREW AXSOS 4.0MM / L30MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6892647
• MDR Text Key: 87476641
• Report Number: 0008031020-2017-00550
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K050512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 371530
• Device Lot Number: J01439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• 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