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	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that, during a tha, a surgeon noticed a mis-processing on the screw head.A spare was used instead.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a 6.5 cancellous bone screw 25mm was reported.The event was confirmed.Method & results product evaluation and results: visual inspection of the returned device noted the following: the edge of the screw head was returned fractured.Damage on the shank and threads of the screw is consistent with contact against a hard object.The screw was further examined using a scanning electron microscope sem material analysis of the returned device noted the following: the edge of the screw head fractured in overload originating on the distal surface and propagating proximally.Damage on the shank was consistent with contact against a hard object.No evidence of a high driving torque was observed on the drive feature.Eds showed the screw base alloy was consistent with the drawing.Based on the given information, no identifiable materials discrepancies were observed on the surfaces examined.The product manufacturing cell representative reviewed the event and stated: -[.] damage is present on sections of the thread proximal to the shank, the shank as well as the head of the screw.From the same report, it was noted that the damage is consistent with "contact against a hard surface".While the report also noted the presence of machine lines, it can be seen that the lines may have been caused by the same contact against a hard object.Additional investigation was also performed by the supplier.The investigation concluded that damage was not a machining defect.Multiple stages of visual inspection are in place to ensure the issue at hand would have been identified before the product is released to the field.Therefore, the fracture could not have occurred during manufacturing.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: no further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that, during a tha, a surgeon noticed a mis- processing on the screw head.A spare was used instead.

• 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
• MDR Report Key: 9378373
• Report Number: 0002249697-2019-03870
• Device Sequence Number: 11523139
• Product Code: HWC
• UDI-Device Identifier: 07613327036992
• UDI-Public: 07613327036992
• Combination Product (Y/N): N
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 2030-6525-1
• Device Catalogue Number: 2030-6525-1
• Device Lot Number: YE356P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 02/05/2020
• 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