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

Catalog Number 0210110100

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2014

Event Type  malfunction  

Event Description

It was reported that the interpulse handpiece with coaxial bone cleaning tip was being used in a procedure when it was observed that an o-ring was broken.There was no report of any fragment from the o-ring falling into the surgical site.The procedure was completed successfully, with no patient or user injuries, and no adverse consequences.

Manufacturer Narrative

The unit was received in its original blister with label.However, the coaxial bone cleaning tip was not returned.A broken black o-ring was found inside the unit¿s blister, thus confirming the reported ¿broken o-ring¿ condition.A definite root cause could not be determined.The device was scrapped at the manufacturer.

Event Description

It was reported that the interpulse handpiece with coaxial bone cleaning tip was being used in a procedure when it was observed that an o-ring was broken.There was no report of any fragment from the o-ring falling into the surgical site.The procedure was completed successfully, with no patient or user injuries, and no adverse consequences.

Manufacturer Narrative

A follow up report will be filed after the device is received and the quality investigation has been completed.Not yet received by manufacturer.

• Brand Name: INTERPULSE HANDPIECE WITH COAXIAL BONE CLEANING TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001 006
• 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: 3922336
• MDR Text Key: 4705241
• Report Number: 0001811755-2014-02423
• 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,Followup
• Report Date: 06/10/2014

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: 0210110100
• Device Lot Number: 14113012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 07/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• 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