MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN DRILL; INSTRUMENT

Catalog Number UNK_SEL

Device Problem Device Slipped (1584)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported: the operation was going good, but it was the radiolucent drill used for the final distal screw insertion caused the slide to slip and injured the artery, so bleeding occurred.Treated by suturing the injured artery, then drilling again and inserting the screw.Completed to the operation.

Manufacturer Narrative

Correction: refer to d10/h3 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 was also not possible as no further information was made available.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition is unknown.

Event Description

It was reported: the operation was going good, but it was the radiolucent drill used for the final distal screw insertion caused the slide to slip and injured the artery, so bleeding occurred.Treated by suturing the injured artery, then drilling again and inserting the screw.Completed to the operation.

• Brand Name: UNKNOWN DRILL
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9341332
• MDR Text Key: 178232788
• Report Number: 0008031020-2019-01861
• Device Sequence Number: 1
• Product Code: HTW
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention