MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_48 /50MM CANCELLOUS SCREW; SCREW, FIXATION, BONE

Catalog Number UNK_JR

Device Problem Material Erosion (1214)

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

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Secure fit ad (ceramic on ceramic shell) / alumina insert 28mm 48 / 50mm / cancellation screw.G1 ceramic on ceramic shell revision ope, screw hole of screw was broken and could not be pulled out by screwdriver.The screw was removed with cup.A doctor commented, "the removed alumina insert had a round wound.Did this happen due to interference with the screw head?".Sr comment: "when the alumina insert is inserted into the secure fit ad, there is a space between the shell and the shell.Even if the screw is not completely tightened in the first ope, the insert will fit.

• Brand Name: UNKNOWN_48 /50MM CANCELLOUS SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9983135
• MDR Text Key: 188804472
• Report Number: 0002249697-2020-00785
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2020

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_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other