MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN AXSOS 3 PROXIMAL SCREW FOR LATERAL HUMERAL PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Difficult to Remove (1528)

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

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported: "the customer reported that struggled to remove a proximal lateral humeral plate from a patient (axsos 3 ).They further reported that the screw heads got rounded and the screw driver would not engage.In order to tackle that they tried using a universal extractor kit (from another supplier) which did not work) after that they used a single use extraction kit which eventually worked (again from another supplier)." surgical delay of 90 minutes.

Manufacturer Narrative

Correction: please note corrections to h3, h6 method code.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.The operative technique instructs user that, in the extreme event of broken or stripped screws, the stryker implant extraction set includes a variety of broken screw removal instruments.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, according to the risk management file, possible cause of failure could be the application of excessive force during screw tightening, which after a course of time might have resulted into cold welding of screw-heads with plate interface.As per the event description- the screw-heads were rounded (stripped), in such events, stryker implant extraction set could have been used.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device discarded.

Event Description

As reported: "the customer reported that struggled to remove a proximal lateral humeral plate from a patient (axsos 3 ).They further reported that the screw heads got rounded and the screw driver would not engage.In order to tackle that they tried using a universal extractor kit (from another supplier) which did not work) after that they used a single use extraction kit which eventually worked (again from another supplier)." surgical delay of 90 minutes.

• Brand Name: UNKNOWN AXSOS 3 PROXIMAL SCREW FOR LATERAL HUMERAL PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10702121
• MDR Text Key: 218725612
• Report Number: 0008031020-2020-02344
• Device Sequence Number: 1
• Product Code: HRS
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• 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: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1