MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO COAXIAL FAN SPRAY TIP; LAVAGE, JET

Catalog Number 0210018100

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

It was reported that the coaxial fan spray tip came off during a procedure and fell into the surgical site.The tip was removed by hand and the procedure was completed successfully, with no patient or user injuries, and no adverse consequences.

Manufacturer Narrative

(b)(4) new units were returned at the manufacturer for evaluation.All units were visually inspected.Two units were received with suction tubes detached from tip inserts.Suction tube pull test was performed to the other (b)(4) units three units were found below the 50 lbf parameter.Glue applied was not uniformly distributed through the connected parts.Based on device risk documentation and evaluation of units received from previous similar events, the most probable root causes for this condition can be associated, but not limited to: the tip might break/ fall-off if the assembly of the tip is improperly bonded (excess/less adhesive or solvent) producing weak or brittle bonding between parts.Incorrect assembly process (not enough insertion of suction tube) or too much force applied during assembly at the manufacturing process.Possible application of too much force during the tip assembly to the irrigation handpiece at the set-up stage in the operating room or during device usage.Poor gap design for mating parts (suction tube and tip insert).The device was scrapped at the manufacturer.

• Brand Name: COAXIAL FAN SPRAY TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3782545
• MDR Text Key: 4438448
• Report Number: 0001811755-2014-01576
• 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: 04/03/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 0210018100
• Device Lot Number: 14062012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2014
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2014
• 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