MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 25MM; SCREW, FIXATION, BONE

Catalog Number 2030-6525-1

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the product history records indicate that devices were manufactured and accepted into final stock with no reported relevant discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that, during a tha, a nurse was opening the outer blister pack, the tyvek sheet was delaminated.A spare was used instead.

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: as per manufacturing engineer, "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 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." see attached email.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.Conclusion: the alleged event could not be confirmed nor the exact cause of the delaminated tyvek could not 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 may lead to delamination." if additional information becomes available, this investigation will be reopened.

Event Description

It was reported that, during a tha, a nurse was opening the outer blister pack, the tyvek sheet was delaminated.A spare was used instead.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 25MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7926567
• MDR Text Key: 122640445
• Report Number: 0002249697-2018-03141
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327036992
• UDI-Public: 07613327036992
• Combination Product (y/n): N
• PMA/PMN Number: K894124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 2030-6525-1
• Device Lot Number: ED5355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other