MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 25MM; SCREW, FIXATION, BONE

Model Number	2030-6525-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional 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 review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.
Event or Problem Description
A patient who underwent tha on (b)(6) 2016, complained of right hip pain.X-rays revealed that the cup side was prolapsed.One screw (out of three) was found to be broken when the cup was removed.The molar floor was in metallosis.The doctor decided to leave the broken screw in place and proceeded with the operation because removing the entire screw would be too risky.After that, the operation was completed as planned.
Event or Problem Description
A patient who underwent tha on (b)(6) 2016, complained of right hip pain.X-rays revealed that the cup side was prolapsed.One screw (out of three) was found to be broken when the cup was removed.The molar floor was in metallosis.The doctor decided to leave the broken screw in place and proceeded with the operation because removing the entire screw would be too risky.After that, the operation was completed as planned.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and wear/metallosis involving a hip screw was reported.Crack/fracture was confirmed via evaluation of provided photographs of the device.Wear/metallosis was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photo shows two recently explanted screws.One of the screw tips has fractured off and is not present in the photo.Nothing remarkable is observed on the other screw.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to cup malposition.Intraoperatively, fracture of one of the screws and metallosis were observed.The reported device was not returned however photographs were provided for review.The photo shows two recently explanted screws.One of the screw tips has fractured off and is not present in the photo.Nothing remarkable is observed on the other screw.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 25MM
• Common Device Name: 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16513283
• Report Number: 0002249697-2023-00243
• Device Sequence Number: 6366617
• Product Code: HWC
• UDI-Device Identifier: 07613327036992
• UDI-Public: 07613327036992
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 2030-6525-1
• Device Catalogue Number: 2030-6525-1
• Device Lot Number: N05MTR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian