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

Catalog Number	2030-6525-1
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
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.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
Only single layer disinfectant package.The package was missing the inner blister.
Event or Problem Description
Only single layer disinfectant package.The package was missing the inner blister.
Additional Manufacturer Narrative
An event regarding alleged packaging issue involving an other hip screw was reported.The event was not confirmed.Conclusion: it was reported that the packaging was missing the inner blister.The product was not returned, however, a photo was provided where the inner blister was not shown.This event was furthered review by the packaging team and stated that "after reviewing both the pi and the returned blister, there is no obvious evidence that this event was caused by the manufacturing operations within the packaging cell.The dhr (router) was also reviewed for the lot in question and no discrepancies were noted.Additionally, dcp (b)(4) allows for incorrect packaging component at an occurrence rate of (b)(4)units.Since we have not had a similar issue in the recent past, it falls within our allowable defect rate per the dcp." see attached email.The exact cause of the event could not be determined because the device was not returned to stryker orthopaedics.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 25MM
• Common Device Name: DEVICE SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7707791
• Report Number: 0002249697-2018-02254
• Device Sequence Number: 1365327
• Product Code: HWC
• UDI-Device Identifier: 07613327036992
• UDI-Public: 07613327036992
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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: 08/31/2022
• Device Catalogue Number: 2030-6525-1
• Device Lot Number: YK005T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 11/19/2018
• 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