MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 11CM IQ KNIFE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B107
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, the knife/device broke.It was also reported there were no delays and no adverse consequences as a result of this event.No further information was provided.
Additional Manufacturer Narrative
H6; the reported product involved with this event was returned for evaluation and the reported failure of tip breakage was confirmed.The product was evaluated by product engineering who concluded that the fracture reported by the customer was caused by a fracture that initiated at a defect in the dish of the part.Based on this information, the manufacturing process can be ruled out.This defect was likely caused from contact with another surgical tool or metal device in the surgical site.The instructions for use(ifu) for the tips and sleeves contain the following indication for use; "tip and sleeve sets intended for soft tissue may be used in surgical procedures including neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and thoracoscopic surgery".
Event or Problem Description
It was reported that during a surgical procedure, the the knife/device broke.It was also reported there were no delays and no adverse consequences as a result of this event.No further information was provided.

• Brand Name: 11CM IQ KNIFE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10373842
• Report Number: 0001811755-2020-02084
• Device Sequence Number: 11513577
• Product Code: LFL
• UDI-Device Identifier: 37613327422482
• UDI-Public: 37613327422482
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/02/2020

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: Health Professional
• Device Catalogue Number: 550025B107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1