MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 30MM; SCREW, FIXATION, BONE

Catalog Number	2030-6530-1
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding alleged packaging issue involving a hip screw was reported.The event was confirmed.Device evaluation and results: the outer blister tyvek lid was peeled back and the tyvek lid had separated or delaminated, leaving part of the lid still stuck to the blister.Medical records received and evaluation: the event is not related to patient factors.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.The inner tyvek lid delaminated, leaving part of the lid still stuck to the blister.The exact cause of the torn tyvek could not be determined.No issues with the packaging seal were observed as inspected by the packaging sme.There is no indication at this time that the sterility of the device was compromised or that there was anything wrong with the product itself.The packaging sme indicated that the product was manufactured to specifications.If additional information becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.
Event or Problem Description
It was reported that, during a tha, when a nurse was opening the tyvek sheet, it was delaminated.A spare was used instead.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7474856
• Report Number: 0002249697-2018-01265
• Device Sequence Number: 172741
• Product Code: HWC
• UDI-Device Identifier: 07613327037005
• UDI-Public: 07613327037005
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: 11/30/2022
• Device Catalogue Number: 2030-6530-1
• Device Lot Number: Y90P2L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/30/2018
• 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