MAUDE Adverse Event Report: SYMMETRY SURGICAL LLC CLASSIC PLUS; NEEDLE HOLDER

Catalog Number 36-1002

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

The instrument had been in use for over a year and does not represent new items in inventory.Containment actions are not necessary as a result.The instrument has not yet been received for evaluation.There has been a total of 5,387 sold of this product code with no additional complaints recorded for a similar occurrence.A follow up report will be submitted once we have completed our evaluation.

Event Description

During a carotid surgery the inserts of the needle holder fell off and into the patient.The piece was retrieved with no harm to the patient.

Manufacturer Narrative

Corrected data: corrected the part number to 36-1002.Corrected the lot number to 00000716.Corrected the udi number to (b)(4).Upon receiving the returned device, it confirmed that the instrument part number was 36-1002 rather than the initially reported product.Based on the lot number of the device, it was purchased in october 2016.There were multiple repair dates on the device that were not in alignment with our contract manufactuing site.Additionally, there was evidence that the instrument had been buffed out which is additional evidence that it had been previously repaired.The most recent repair date on the device was (b)(6), 2020 which was a week before the complete was reported.This type of device required regular maintenance to replace the inserts as they wear from use.It is uknown if the inserts were replaced by the outside repair facility.The warranty of this product has been voided by using an outside repair facility, therefore the product cannot be properly evaluated.There has been a total of 5,387 sold of all lots with no additional complaints recorded.Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any additionla patient involvement or need for corrective actions a follow up report will be submitted.

• Brand Name: CLASSIC PLUS
• Type of Device: NEEDLE HOLDER
• Manufacturer (Section D): SYMMETRY SURGICAL LLC; 3034 owen drive; antioch, tn
• MDR Report Key: 10411385
• MDR Text Key: 203117408
• Report Number: 3007208013-2020-00022
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 00887482009574
• UDI-Public: 00887482009574
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 36-1002
• Device Lot Number: 00000716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention