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

Catalog Number 0210118100

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

It was reported that the interpulse handpiece with coaxial fan spray tip was being tested when it was observed to come apart into pieces.There was no patient involvement, and no associated procedure.There were no user injuries or adverse consequences.

Manufacturer Narrative

All units were visually inspected.It was observed that all suction tubes were connected to tip inserts.A manual pull test was performed to suctions tubes and the tubes were observed to detach from tip inserts.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 can potentially 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 claimed condition was confirmed, and the devices were scrapped by the manufacturer.

• Brand Name: INTERPULSE HANDPIECE WITH 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: 3765662
• MDR Text Key: 4374510
• Report Number: 0001811755-2014-01448
• 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: 03/26/2014

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: 0210118100
• Device Lot Number: 14052012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2014
• 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