MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN AXSOS SCREW; IMPLANT

Catalog Number UNK_SEL

Device Problems Material Erosion (1214); Difficult to Remove (1528)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

As reported: "axos dmt extraction surgery.Two locking screw heads slipped.The doctor tried to scrape with a carbide drill.Eventually, it was closed with the plate and two screws left.The operation is over and scheduled to be re-open on december 17th." it was further clarified that the screws had stripped and the extraction occurred on december 17th.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "axos dmt extraction surgery.Two locking screw heads slipped.The doctor tried to scrape with a carbide drill.Eventually, it was closed with the plate and two screws left.The operation is over and scheduled to be re-ope on (b)(6)." it was further clarified that the screws had stripped and the extraction occurred on (b)(6).

• Brand Name: UNKNOWN AXSOS SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9567103
• MDR Text Key: 189321108
• Report Number: 0008031020-2020-00098
• Device Sequence Number: 1
• Product Code: HWC
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention