MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO SURGILAV HIGH FLOW TRAUMA TIP; LAVAGE, JET

Catalog Number 0207060000

Device Problem Biocompatibility (2886)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

Customer discarded the product.

Event Description

The user facility reported that there was a hair in the disposable sterile item found prepping for a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: SURGILAV HIGH FLOW TRAUMA TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6558736
• MDR Text Key: 74893832
• Report Number: 0001811755-2017-01234
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0207060000
• Device Lot Number: 15218012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1