MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 16MM; SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.

Catalog Number	2030-6516-1
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that, during a tha, when a nurse was opening the outer blister pack, the tyvek sheet was delaminated.
Additional Manufacturer Narrative
An event regarding alleged packaging issue involving a hip screw was reported.The event was confirmed through the inspection of the device.Conclusion: it was reported that during a tha, the outer tyvek sheet was found delaminated.Visual inspection of the returned device noted that the tyvek sheet was partially attached to the blister on one of the edges.The exact cause of the event could not be determined as insufficient information was provided.No further investigation for this event is possible at this time.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, when a nurse was opening the outer blister pack, the tyvek sheet was delaminated.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 16MM
• Common Device Name: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7793793
• Report Number: 0002249697-2018-02567
• Device Sequence Number: 1195492
• Product Code: HWC
• UDI-Device Identifier: 07613327036978
• UDI-Public: 07613327036978
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/20/2018

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: 04/30/2023
• Device Catalogue Number: 2030-6516-1
• Device Lot Number: X62JTX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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