MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO BONE CLEANING TIP; LAVAGE, JET

Catalog Number	0210010000
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not available to return.
Event or Problem Description
The user facility reported there was debris inside the peel pack found prior to a procedure.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The user facility reported there was debris inside the peel pack found prior to a procedure.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Additional information: product is not available.

• Brand Name: BONE CLEANING TIP
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• MDR Report Key: 7893389
• Report Number: 0001811755-2018-01667
• Device Sequence Number: 168296
• Product Code: FQH
• UDI-Device Identifier: 34546540144165
• UDI-Public: 34546540144165
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• 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 Catalogue Number: 0210010000
• Device Lot Number: 18138012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 09/20/2018
• 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