MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN AXSOS SCREWDRIVER; INSTRUMENT

Catalog Number UNK_SEL

Device Problem Fracture (1260)

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

Event Date 10/25/2019

Event Type  malfunction  

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.Device disposition is unknown.

Event Description

A doctor wrote a letter, in which she said : "stryker screwdrivers should be declared in material vigilance for axsos equipment.Both the handle screwdrivers and the ao quick-release screwdrivers break when removing some screws that are too tight and it is impossible to remove the screws without destroying the screw head.A patient from (b)(6) was entrusted to me for an equipment removal, the surgeon had broken the only axsos screwdriver he had.When i removed this patient's equipment, i broke 2 screwdrivers myself about a month ago.For this last intervention yesterday, i broke 3 screwdrivers of the same brand for the same type of material device.The fact of having destroyed the screw heads to remove the material lengthens the operating time so the risk of infection becomes major, multiple metallic foreign bodies are scattered, while with stronger screwdrivers there would be no particular problem".Additional information reported: "the breakage of these unstable screwdrivers seems to us to occur during the removal of the titanium torx screws, even though they were installed with a torque screwdriver.Note that there is no breakage during installation, but when removing material, both the screwdrivers on the handle and the quick ao snap-on bits.This happened on the other side of (b)(6).And the surgeon who only had a stryker screwdriver could not continue the procedure, the patient was entrusted to us remotely to finish removing the screws and plate and we had the same problem and had to resolve to destroy by metal wick the two screw heads still healthy and unscrewable.When this problem happened again at a few weeks' intervals, knowing that we had had quite a few broken screwdrivers, i asked for a statement.".

• Brand Name: UNKNOWN AXSOS SCREWDRIVER
• Type of Device: INSTRUMENT
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9527507
• MDR Text Key: 193344429
• Report Number: 0008031020-2019-02514
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/27/2019

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 Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1