MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP; LAVAGE, JET

Catalog Number 0210114100

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2014

Event Type  malfunction  

Event Description

It was reported that the interpulse handpiece with coaxial high flow tips were being used in cases when they came apart at the nozzle end between the cone and the connection to the irrigation gun end.It was confirmed that the tips or fragments from the tips did not enter the surgical site.The procedures were completed by putting the tip back on.There were no patient or user injuries, and no adverse consequences.

Manufacturer Narrative

A follow up report will be filed after the devices are received and the quality investigation has been completed.

Event Description

It was reported that the interpulse handpiece with coaxial high flow tips were being used in cases when they came apart at the nozzle end between the cone and the connection to the irrigation gun end.It was confirmed that the tips or fragments from the tips did not enter the surgical site.The procedures were completed by putting the tip back on.There were no patient or user injuries, and no adverse consequences.

Manufacturer Narrative

One (1) tip was returned to the manufacturer for evaluation, and the suction tube was found detached from tip insert / base.Glue residues were observed in the suction tube and the tip insert, but not evenly and uniformly distributed through the bonding areas.The most probable root causes for this condition can be associated, but not limited to: the tip might break or 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: INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW 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: 3735822
• MDR Text Key: 4224140
• Report Number: 0001811755-2014-01236
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/12/2014

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: 0210114100
• Device Lot Number: 14042012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 04/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2014
• 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