MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 25MM; SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.

Catalog Number	2030-6525-1
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
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.Visual inspection by manufacturing engineer, "after reviewing the blister, 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 may lead to delamination.The dhr (router) was also reviewed for the lot in question and no discrepancies were noted.There are also no other obvious input sources from production which could contribute to the delamination on the interior of the outer tyvek.".
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 25MM
• 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: 7890080
• Report Number: 0002249697-2018-02962
• Device Sequence Number: 19424478
• 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
• Report Date (Section B): 09/19/2018

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: 2030-6525-1
• Device Lot Number: ME450D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/19/2018
• 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