MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TPS HANDPIECE CORD; UNIT, OPERATIVE DENTAL

Catalog Number 5100004000

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2014

Event Type  malfunction  

Event Description

It was reported that during equipment testing conducted by a manufacturer field service technician that the retaining nut on the console end unscrews easily.No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported that during equipment testing conducted by a manufacturer field service technician that the retaining nut on the console end unscrews easily.No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

Evaluation conclusion: the device was discarded by the manufacturer.Follow-up report submitted to document device evaluation results.Additionally, while it was confirmed the retaining nut on the connector at the console end of the cable was able to be unscrewed it was still present on the device and was not missing from the device.

• Brand Name: TPS HANDPIECE CORD
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4195362
• MDR Text Key: 5043993
• Report Number: 0001811755-2014-03742
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2014

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: 5100004000
• Device Lot Number: 10216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 10/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1