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

Catalog Number	2030-6525-1
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2018
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 reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: "the screw box looks to have been smashed during delivery and caused the threads of the screw to push through the packaging.".
Additional Manufacturer Narrative
An event regarding alleged pack damage issue involving a bone screw was reported.The event was confirmed.Conclusion: the reported event was confirmed per the visual inspection of the returned device.The packaging damage was most likely caused by excessive/incorrect handling during transportation/storage.A shipment discrepancy report was sent to the distribution.No further investigation for this event is required at this time.
Event or Problem Description
As reported: "the screw box looks to have been smashed during delivery and caused the threads of the screw to push through the packaging.".

• 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: 7440257
• Report Number: 0002249697-2018-01157
• Device Sequence Number: 19096529
• Product Code: HWC
• UDI-Device Identifier: 07613327036992
• UDI-Public: 07613327036992
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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: 01/31/2023
• Device Catalogue Number: 2030-6525-1
• Device Lot Number: DP84V4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 06/06/2018
• 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: 80 YR