MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 20MM; SCREW, FIXATION, BONE

Catalog Number	2030-6520-1
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
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
Packaging of screw looked compromised.Circulator noticed before screw was placed on sterile field.Opened new screw and proceeded on with case, there was no delay to surgery.Per rep, packaging "appears to be discolored and that is the sole reason for reporting.".
Additional Manufacturer Narrative
An event regarding a discolored tyvek lid in the packaging involving a bone screw was reported.The event was confirmed.The reported screw was returned inside the original blister pack along with the implant stickers.The tyvek lid was confirmed to be discolored.Clinician review was not performed as there is no indication that the event was related to patient factors.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.There have been no other events for the referenced lot.The reported event was confirmed and the root cause was determined to be a manufacturing non-conformance.An nc was raised, regarding the discolored tyvek lid in packaging and to define the root cause and corrective actions.Per said nc, the cause of the translucency in the tyvek lid material is an overheating of the material.The nc found that the scope is restricted to the single piece, mentioned in the complaint.This is due to the 100% verification of each product individually, the individual sealing, and the independent inspection process within the room.In addition, an occurrence of incorrect sealing parameters of 1 in 25,000 parts is allowed, which is well within the expected rates of manufacturing.
Event or Problem Description
Packaging of screw looked compromised.Circulator noticed before screw was placed on sterile field.Opened new screw and proceeded on with case, there was no delay to surgery.Per rep, packaging "appears to be discolored and that is the sole reason for reporting.".

• Brand Name: 6.5 CANCELLOUS BONE SCREW 20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7837161
• Report Number: 0002249697-2018-02738
• Device Sequence Number: 13750238
• Product Code: HWC
• UDI-Device Identifier: 07613327036985
• UDI-Public: 07613327036985
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/25/2018

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: 03/31/2023
• Device Catalogue Number: 2030-6520-1
• Device Lot Number: 3Y2KPL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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