MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI 3.5MM / L40MM; PLATE, FIXATION, BONE

Model Number 661440

Device Problem Defective Device (2588)

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

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The following event was reported that: "we have just received a material ovigilance concerning the axsos cortical screws.On the radio, the screws were bent, and the threads were turning.Screws concerned: 2 screws bent during placement: 1 cortical 3.5 in 32mm and 1 cortical 3.5 in 40mm: and 2 screws with bad thread: 2 cortical 3.5 in 40mm and 2 locked screws in 28mm.Consequences: the surgeon removed the screws and put in new ones.¿.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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.However, possible causes of failure could be handling failure, angulated insertion, interference with other screws, etc.If device is returned or any further information is provided, the investigation report will be reassessed.Device disposition is unknown.

Event Description

The following event was reported that: "we have just received a materialovigilance concerning the axsos cortical screws.On the radio, the screws were bent, and the threads were turning.Screws concerned: 2 screws bent during placement: 1 cortical 3.5 in 32mm and 1 cortical 3.5 in 40mm: and 2 screws with bad thread: 2 cortical 3.5 in 40mm and 2 locked screws in 28mm.Consequences: the surgeon removed the screws and put in new ones.¿.

Manufacturer Narrative

Correction: refer to d9/h3, h6 method, results & conclusion code.The reported event could not be confirmed, since the returned device shows no visible damage and is conforming to specifications.The device inspection revealed the following: overall 5 screws were received.However, none of the received screws of the reported catalog number were found to be defective.No form of deformation or damage could be observed all throughout the screw.The threads were intact, no bend throughout the length could be observed and the hex in the head was also secure.A review of the device history for the reported lot did not indicate any abnormalities.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, since no product deficiency could be observed, the alleged failure cannot be confirmed and therefore the issue is deemed to be user related.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

The following event was reported that: "we have just received a materialovigilance concerning the axsos cortical screws.On the radio, the screws were bent, and the threads were turning screws concerned: 2 screws bent during placement: 1 cortical 3.5 in 32mm and 1 cortical 3.5 in 40mm: and 2 screws with bad thread: 2 cortical 3.5 in 40mm and 2 locked screws in 28mm consequences: the surgeon removed the screws and put in new ones.¿.

• Brand Name: CORTEX SCREW AXSOS 3 TI 3.5MM / L40MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10609916
• MDR Text Key: 209428243
• Report Number: 0008031020-2020-02284
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252580416
• UDI-Public: 07613252580416
• Combination Product (y/n): N
• PMA/PMN Number: K123964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2021

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 Model Number: 661440
• Device Catalogue Number: 661440
• Device Lot Number: J40142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 11/13/2020; 02/04/2021
• Supplement Dates FDA Received: 12/10/2020; 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1