MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 12CM IQ MICRO CLAW; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B315
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Actual device not returned for evaluation.Only unopened devices from the same lot returned.
Event or Problem Description
It was reported that during a posterior cervical decompression, pediatric surgical procedure, the handpiece burned the right hand of the surgeon and also the patients neck.It was also reported that a new tip was fitted and the handpiece continued to overheat.This record addresses one of the tips that contributed to the overheating event.It was also reported there were no adverse consequences as a result of this event.It was further reported that a 10 minute delay occurred as a result of this event.It was also reported that the procedure was completed successfully using a back-up device.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not available for return.
Event or Problem Description
It was reported that during a posterior cervical decompression, pediatric surgical procedure, the handpiece burned the right hand of the surgeon and also the patients neck.It was also reported that a new tip was fitted and the handpiece continued to overheat.This record addresses one of the tips that contributed to the overheating event.It was also reported there were no adverse consequences as a result of this event.It was further reported that a 10 minute delay occurred as a result of this event.It was also reported that the procedure was completed successfully using a back-up device.

• Brand Name: 12CM IQ MICRO CLAW
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11309633
• Report Number: 0001811755-2021-00546
• Device Sequence Number: 3803721
• Product Code: LFL
• UDI-Device Identifier: 37613327422383
• UDI-Public: 37613327422383
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K190070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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
• Operator of Device: No Information
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 550025B315
• Device Lot Number: 20202017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1