MAUDE Adverse Event Report: AESCULAP INC. ANKENEY STERNAL RETR.SET W/6 BLD.35X35MM; RETRACTOR

Model Number MG509R

Device Problem Mechanical Jam (2983)

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

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap inc.That a ankeney sternal retr.Set w/6 bld.35x35mm (part # mg509r) was used during an unknown procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the crank handle became stuck and was not able to be turned while inside the patient.The handle was forcibly turned using a mallot, which resulted in the creation of metal shavings.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.

Manufacturer Narrative

Manufacturer evaluation: the complaint device was returned to the manufacturer for evaluation.A functional evaluation revealed that the handle crank was stuck.The crank handle was replaced and the surface was reworked to resolve the issue.The device history records (dhr) was reviewed for the identified serial number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.An investigation of the returned device confirmed the reported issue of stuck handle crank.The handle crank requires routine maintenance with the application of oil to maintain smoothness.Therefore, the most probable root cause was noted as being improper device maintenance.

• Brand Name: ANKENEY STERNAL RETR.SET W/6 BLD.35X35MM
• Type of Device: RETRACTOR
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 11970563
• MDR Text Key: 261268448
• Report Number: 2916714-2021-00117
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 04046955057207
• UDI-Public: 4046955057207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MG509R
• Device Catalogue Number: MG509R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other