MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY; OSTEOTOME

Catalog Number	46-3052
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was unable to confirm a part number or provide a picture.However, a review of the customer's purchase history showed that only one osteotome part number has been purchased.This purchase occurred in november 2020.This part number has been used for the investigation and this report.The customer reported the osteotome chipped while levering a connector off of a rod.It was confirmed that this was a metal rod inside the patient.Levering the osteotome against the metal rod will cause damage to the osteotome as this is off-label use that is beyond the intended use for this device.This is an isolated event with (b)(4) sold of all lots.Based on the above information, no further actions are required.This can be seen as the final report.If additional information is obtained that is pertinent to the investigation or alleges additional patient involvement, a follow up report will be submitted.User facility report received uf report# (b)(4).
Event or Problem Description
The customer alleged that during the removal of posterior spinal hardware t9 to l1 a piece of the osteotome instrument broke off and fell into the patient.The surgeon stated that at one point a small piece of the straight osteotome chipped off in an attempt to lever the across connector off of the rod.The piece was removed from the surgical site after looking for it.However, an x-ray was performed and confirmed that there was 1mm size piece still remaining inside the patient.The surgeon determined that a second surgery was not needed to remove the 1mm piece.There was no additional harm to the patient.

• Brand Name: SYMMETRY
• Common Device Name: OSTEOTOME
• 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: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 15279912
• Report Number: 3007208013-2022-00032
• Device Sequence Number: 20346116
• Product Code: HWM
• UDI-Device Identifier: 00887482014011
• UDI-Public: 00887482014011
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/23/2022

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: 46-3052
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown