MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRAIGHT; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5450800307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during a spinal tumor surgery the dura was injured.It was further reported that there were no surgical delay and the procedure was completed successfully.
Additional Manufacturer Narrative
The reported event, for product operating differently than expected and resulting in non-targeted tissue exposes to emulsification, was not confirmed as the device was not returned for evaluation.Potential causes for this issue are as follows; poor tip design - sharp edges, key feature out of spec - incomplete debur, poor line of sight.Without the device, the root cause cannot be determined.Device discarded by customer.
Event or Problem Description
It was reported that during a spinal tumor surgery the dura was injured.It was further reported that there were no surgical delay and the procedure was completed successfully.

• Brand Name: STRAIGHT
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9601425
• Report Number: 0001811755-2020-00070
• Device Sequence Number: 19377970
• Product Code: LFL
• UDI-Device Identifier: 37613252026670
• UDI-Public: 37613252026670
• Combination Product (Y/N): N
• PMA/510(K) Number: K020220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 5450800307
• Device Lot Number: M0018248
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other