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

Catalog Number 371530S

Device Problems Component Falling (1105); Degraded (1153); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported by the stryker clinical support specialist, "i was supporting a trauma case using the 4mm axsos system, during the procedure on insertion of a locking screw, the head of the screw has sheared off, the shaft of the screw remains in the plate implanted in the patient.The surgeon has took responsibility as user error and does not wish to take the incident any further." update 10july 2015: it was reported that the head of the screw was dropped on the floor and was unable to be found.The surgery was completed with the shaft of the screw remaining in the plate and the surgeon was satisfied with the placement of the remaining part of the screw.No delay to surgery the only issue or consequence will arise if the screw has to be removed.

• 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: 4940108
• MDR Text Key: 22864937
• Report Number: 0008031020-2015-00335
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Report Date: 07/08/2015

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 Expiration Date: 01/31/2020
• Device Catalogue Number: 371530S
• Device Lot Number: J03471
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• 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