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

Catalog Number 0210118100

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2014

Event Type  malfunction  

Event Description

It was reported that the ulse handpiece with coaxial fan spray tip broke during set up.There was no patient involvement, and no associated procedure.There were no user injuries or adverse consequences.

Manufacturer Narrative

One (1) tip was returned for evaluation.The unit label was included and lot / part number was confirmed.Suction tube was found detached from tip insert / base.Glue residues were observed in the suction tube and the tip insert, but not even / uniformly distributed through the bonding areas.Based on device risk document and evaluation of units received from previous similar events, 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 device was scrapped by the manufacturer.

• Brand Name: INTERPULSE HANDPIECE WITH COAXIAL FAN SPRAY TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• 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: 3763009
• MDR Text Key: 4550079
• Report Number: 0001811755-2014-01422
• 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: 03/25/2014

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: 14038012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2013
• Initial Date Manufacturer Received: 03/25/2014
• Initial Date FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2014
• 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