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	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
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.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, when a nurse was opening the blister package, the tyvek sheet was delaminated.A spare was used instead.
Additional Manufacturer Narrative
An event regarding alleged packaging issue involving a hip screw was reported.The event was not confirmed.Method & results: -device evaluation and results: the blister tray was returned with the opened tyvek sheet partially attached on one of the edges along with all the labels.Refer attached picture.-clinician review: no medical records were received for review with a clinical consultant.-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.Conclusion: the alleged event could not be confirmed nor the exact cause of the delaminated tyvek could be determined.No issues with the packaging seal were observed as inspected by the packaging sme.The packaging sme stated "after reviewing both the pi and the blister itself, there is no obvious evidence that the blister package was improperly sealed.Specifically, no sign of over-sealing (translucent seals, warped flanges) were observed that that may potentially lead to separation of the tyvek material from itself." if additional information becomes available, this investigation will be reopened.
Event or Problem Description
It was reported that, during a tha, when a nurse was opening the blister package, the tyvek sheet was delaminated.A spare was used instead.

• 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: 7946916
• Report Number: 0002249697-2018-03240
• Device Sequence Number: 930324
• Product Code: HWC
• UDI-Device Identifier: 07613327036978
• UDI-Public: 07613327036978
• 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,Followup
• Report Date (Section B): 01/24/2019

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: 06/30/2023
• Device Catalogue Number: 2030-6516-1
• Device Lot Number: HT7WWD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 01/24/2019
• 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