MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOMATIC HIGH VACUUM FOOT PUMP; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0206500000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Hearing Loss (1882); No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the metal valve on the end of the device popped off.There was no associated procedure as the event occurred during testing.However, it was further reported at the time that a nurse was being evaluated for a potential hearing injury.Additional information has been requested from the user facility.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that the metal valve on the end of the device popped off.There was no associated procedure as the event occurred during testing.It was initially reported that a nurse standing next to the tank needed to be evaluated for potential hearing injuries but it was later confirmed that no follow up care was needed and there were no adverse consequences to report.

• Brand Name: AUTOMATIC HIGH VACUUM FOOT PUMP
• Common Device Name: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8293133
• Report Number: 0001811755-2019-00452
• Device Sequence Number: 19171716
• Product Code: JDZ
• UDI-Device Identifier: 04546540039378
• UDI-Public: 04546540039378
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0206500000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1