MAUDE Adverse Event Report: SYMMETRY SURGICAL LLC SYMMETRY RAPIDCLEAN; KERRISON RONGEUR

Catalog Number 58-3200J-BD

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The screw was returned with the product.Upon evaluating, it was noted that the screw had damage that was consistent with tampering with the screw in some way.This customer has had multiple recent complaints for the screws becoming loose.It can be determined that there is a specific problem going on in the sterile processing department.There has been a total 328 sold of all lots with 4 total complaints recorded for similar occurrences.Of the four complaints, 2 were received by this customer.The other two complaints were from (b)(6) 2019 and 2015 and were both found to have damage to the screws as well.As a courtesy, we are letting the customer send in their remaining sets to repaired by our contract repair facility and the screws reset.Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions, a follow up report will be submitted.

Event Description

The screw fell out of the 3mm kerrison and fell into the spinal erea.It took some time to find the screw, but it was removed with no further harm to the patient.

• Brand Name: SYMMETRY RAPIDCLEAN
• Type of Device: KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL LLC; 3034 owen drive; antioch, tn
• Manufacturer (Section G): SYMMETRY SURGICAL LLC; 3034 owen drive; antioch, tn
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, tn ; 9645290
• MDR Report Key: 10512221
• MDR Text Key: 209157195
• Report Number: 3007208013-2020-00024
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00887482102527
• UDI-Public: 00887482102527
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 58-3200J-BD
• Device Lot Number: T01-81802648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• 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: Reuse
• Patient Sequence Number: 1