MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO BONE VAC; TRAP, STERILE SPECIMEN

Catalog Number	5400800000
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device received but awaiting evaluation results.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device, it was noted that there was foreign material in the pack during visual inspection prior to a surgical procedure.It was also reported that there was no adverse consequences and no delays as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: 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 that there was foreign material in the pack during visual inspection prior to a surgical procedure.It was also reported that there was no adverse consequences and no delays as a result of this event and the procedure was completed successfully.

• Brand Name: BONE VAC
• Common Device Name: TRAP, STERILE SPECIMEN
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11760885
• Report Number: 0001811755-2021-00764
• Device Sequence Number: 1060570
• Product Code: BYZ
• UDI-Device Identifier: 37613327502986
• UDI-Public: 37613327502986
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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 Catalogue Number: 5400800000
• Device Lot Number: 20197B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1