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

Model Number	2030-6535-1
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11590094
• Report Number: 0002249697-2021-00561
• Device Sequence Number: 20028870
• Product Code: HWC
• UDI-Device Identifier: 07613327037012
• UDI-Public: 07613327037012
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR