MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.0MM ROUND FAST CUTTING BUR; BUR, DENTAL

Catalog Number	1608006137
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device, it was noted during visual inspection.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device, it was noted during visual inspection.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
H6; the reported product involved with this event was returned for evaluation and the reported failure of packaging damaged/sterility compromised was confirmed.The device was sent to the packaging engineering team who concluded that it is likely that the damage to the packaging occurred during distribution (including handling) or storage of the product.The handling may have been more aggressive that expected or an unexpected event (such as a crush) occurred.A review of the product label indicates by way of an expandable label icon "do not use if package is damaged".

• Brand Name: 4.0MM ROUND FAST CUTTING BUR
• Common Device Name: BUR, DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9258227
• Report Number: 0001811755-2019-03593
• Device Sequence Number: 3763944
• Product Code: EJL
• UDI-Device Identifier: 04546540030733
• UDI-Public: 04546540030733
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 01/16/2020

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 Expiration Date: 08/01/2024
• Device Catalogue Number: 1608006137
• Device Lot Number: 19231017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1