MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 35MM; SCREW, FIXATION, BONE

Model Number 2030-6535-1

Device Problems Fracture (1260); Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

Reported event: an event regarding crack/ fracture and loosening involving a hip screw was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events (crack/fracture) for the reported lot.There have been 1 other similar events (loosening) for the reported lot.Conclusion: it was reported that the patient had a revision due to shell loosening and migration, and a broken screw.The event could not be confirmed nor the exact cause be determined because insufficient information was provided.Additional information including patient details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported that the patient's right hip was revised due to shell loosening and migration, and a broken screw.There was no known cause or contributor for the loosening or migration.There are no allegations against any other implants.A 50d cluster hole shell and torx bone screw were revised to a 58f tritanium shell with hex screws.Rep confirmed that no further information would be released by the hospital or surgeon.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 35MM
• 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: 11590094
• MDR Text Key: 249909757
• Report Number: 0002249697-2021-00561
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327037012
• UDI-Public: 07613327037012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894124
• 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: 03/30/2021

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 Expiration Date: 08/31/2017
• Device Model Number: 2030-6535-1
• Device Catalogue Number: 2030-6535-1
• Device Lot Number: MLM6LL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2012
• 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
• Patient Age: 52 YR