MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO; UNKNOWN

Catalog Number UNK_INS

Device Problem Metal Shedding Debris (1804)

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

Event Date 03/01/2017

Event Type  malfunction  

Event Description

The customer reported that the device generated metal shavings during a case at the user facility.The user facility was not aware of the specific device that caused the reported event.The complainant was not aware of any delay in surgery, medical intervention, or adverse consequences.

Event Description

The customer reported that the device generated metal shavings during a case at the user facility.The user facility was not aware of the specific device that caused the reported event.The complainant was not aware of any delay in surgery, medical intervention, or adverse consequences.

Event Description

The customer reported that the device generated metal shavings during a case at the user facility.The user facility was not aware of the specific device that caused the reported event.The complaintant was not aware of any delay in surgery, medical intervention, or adverse consequences.

Manufacturer Narrative

The reported event, handpiece has sharp at points, could not be duplicated as the device was not returned to stryker for evaluation.The user facility reported that they hit a nail with the device causing it to have the sharp edge.Although there was not a confirmed failure, based on a review of complaints with a similar event, a possible cause most often identified in relation to a rough/sharp point on a device is being dropped or mishandled.The event did not involve a product problem indicating a non-conformity or unanticipated hazard.No further action is required at this time.

Event Description

The customer reported that the device generated metal shavings during a case at the user facility.The user facility was not aware of the specific device that caused the reported event.The complainant was not aware of any delay in surgery, medical intervention, or adverse consequences.

• Type of Device: UNKNOWN
• 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: 6488895
• MDR Text Key: 78475965
• Report Number: 0001811755-2017-00843
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2017

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: UNK_INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/12/2017; 06/27/2017; 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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