MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT; SMALL BONE POWERED SURGICAL SYSTEMS

Catalog Number 5100015250

Device Problems Break (1069); Unintended Ejection (1234)

Patient Problems Laceration(s) (1946); No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Event Description

The sales representative reported that the user facility experienced the device releasing the bur into the humerus during a shoulder revision surgery.The doctor made a larger incision to extract the bur from the patient.There was a 60 minute delay reported for the surgery length.Medical intervention to the patient was not reported for this event.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

The user facility reported that the surgeon was using the drill to remove cement during a shoulder revision surgery and the bur came out of the attachment and fell into the humerus canal and broke into 2 pieces.There was no patient impact, no medical intervention, and no adverse consequences.There was a 60 minute delay for this event.

• Brand Name: MICRODRILL SERIES STRAIGHT ATTACHMENT
• Type of Device: SMALL BONE POWERED SURGICAL SYSTEMS
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7373686
• MDR Text Key: 103565458
• Report Number: 0001811755-2018-00547
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• PMA/PMN Number: K032117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5100015250
• Device Lot Number: 12280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1608-002-013 4.7MM ROUND BUR SERIAL UNKNOWN; 1608002013, 4.7MM ROUND BUR, UNKNOWN SERIAL; 6400-015-000 REMB MICRODRILL SERIAL (B)(4); 6400015000 REMB MICRO DRILL, SERIAL (B)(4); THE 1608-002-013 4.7MM ROUND BUR SERIAL UNKNOWN; THE 6400-015-000 REMB MICRODRILL SERIAL (B)(4)
• Patient Outcome(s): Other
• Patient Age: 59 YR