MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY KERRISON RONGEUR

Model Number 53-1661

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 06/01/2018

Event Type  malfunction  

Event Description

During the acdf (anterior cervical discectomy and fusion), the symmetry sharp kerrison tip broke off.The surgeon ordered an x-ray.The symmetry sharp kerrison tip could not be identified in the x-ray.The symmetry sharp kerrison tip could not be found in the surgical field.The patient was sent to recovery in stable condition.No untoward effects.

Manufacturer Narrative

Symmetry surgical is providing this summary in response to uf/importer report #(b)(4).This report amends the previous product complaint report (b)(4).We apologize for any inconvenience this issue may have caused.The quality assurance investigation has been updated with the following results: after further investigation, it was confirmed that part # 57-0721, micro kerrison rongeur, was the instrument involved in the reportable incident and part # 53-1661 sharp kerrison rongeur tip was not involved as previously reported in uf/importer report # (b)(4).This was confirmed at customer site as customer has not purchased symmetry surgical sharp kerrison handles or tips in the past.The kerrison rongeur involved in the reportable incident was returned to us for an evaluation.The instrument was purchased in 2014, having over four years of use.Material and hardness data of returned device conformed to current product specifications.Upon initial inspection, instrument is etched with a northfield repair site emblem and repair code "2/18".This is not a symmetry surgical approved repair site.Breakage occurred at the bottom jaw tip of the instrument.Remaining bottom jaw tip material is bent and twisted, and footplate of instrument is misaligned.Condition of instrument is consistent with damage that would occur if user was twisting and torqueing the rongeur while applying excessive force.Excessive force may have been used because rongeur tips were dull, user was taking too big of a bite of material, or user was biting into material too hard for the instrument's intended use.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional informaiton pertinent to the investigation, a subsequent follow up report will be submitted.This report is being submitted retrospectively per fda request.

• Brand Name: SYMMETRY KERRISON RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen drive; antioch, TN 37013 ; 8002513000
• MDR Report Key: 7807021
• MDR Text Key: 118115775
• Report Number: 3007208013-2018-00015
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00887482041673
• UDI-Public: 00887482041673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53-1661
• Device Catalogue Number: 57-0721
• Device Lot Number: AU0514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Ethnicity: Non Hispanic