MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DYNAMIC MESH STD FOR 2.0MM SCREWS, 200X200MM; IMPLANT

Model Number	54-00653
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by a company representative that during an in-coming inspection at distribution the presence of foreign material (hair) was found in the blister package.No medical intervention and no adverse consequences were reported as there was no associated procedure.
Additional Manufacturer Narrative
Related to the reported event, although the product is available it is not obligatorily necessary to return the product including the package to stryker freiburg for investigation because the report of a hair in the package could be clearly confirmed by means of the provided images.The whole package consists of the outer secondary package (directly printed plastic pouch) and the inner primary package (blister with mesh and foam inside) and ifu.Within the visual inspection it was determined that inside the outer secondary package ¿ directly printed plastic pouch - a hair is visible.Furthermore, it could be determined visually that the package was not opened and is in its original delivery condition.Based on the investigation, the root cause of the reported event - hair in the primary package (plastic pouch) - was attributed to a manufacturing related issue ¿ packaging relevant case.According to this, nc #(b)(4) was initiated on 2019-jun-14.Therefore, no further corrective and/or preventive action is considered to be required at this time.
Event or Problem Description
It was reported by a company representative that during an in-coming inspection at distribution the presence of foreign material (hair) was found in the blister package.No medical intervention and no adverse consequences were reported as there was no associated procedure.
Event or Problem Description
It was reported by a company representative that during an in-coming inspection at distribution the presence of foreign material (hair) was found in the blister package.No medical intervention and no adverse consequences were reported as there was no associated procedure.
Additional Manufacturer Narrative
At the time of the initial emdr filing of this complaint it was believed that the product involved is sterile.Upon further review it has been verified that the product, 54-00653, is a non-sterile device.Based on this new and updated/corrected information, the complaint now includes the following non-reportable rationale: ¿there were no adverse consequences to the patient, as there was no patient involvement.We have reviewed the historical reportability of this device.There is no history of adverse consequences for the patient in previous similar events, and no information to indicate that adverse consequences would occur if the event were to happen again.Foreign material/hair within the non-sterile packaging would not hinder a surgery nor cause any adverse consequences for the patient as the material would be removed upon sterilization and eliminate the risk of that material being brought into the operating room.Based on a review of the risk documentation and the reported information regarding this event, a report is not required to be filed.¿.

• Brand Name: DYNAMIC MESH STD FOR 2.0MM SCREWS, 200X200MM
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 8686624
• Report Number: 0008010177-2019-00034
• Device Sequence Number: 2663334
• Product Code: JEY
• UDI-Device Identifier: 04546540237682
• UDI-Public: 04546540237682
• Combination Product (Y/N): N
• PMA/510(K) Number: K983528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2020

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 Model Number: 54-00653
• Device Catalogue Number: 54-00653
• Device Lot Number: 1000330734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 05/27/2019; 05/27/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/01/2019; 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1