MAUDE Adverse Event Report: AESCULAP INC. INSERTER SHAFT; INSTRUMENTS SPINAL MOTION

Model Number	ME246R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.
Event or Problem Description
It was reported to aesculap inc.That a inserter shaft (part # me246r) was used during total disc replacement procedure performed on (b)(6) 2021.According to the complainant, instrument broke during surgery.Additional information was not provided.The complaint device was returned to the manufacturer for evaluation.The adverse event is filed under aic reference xc (b)(4).
Additional Manufacturer Narrative
Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination was performed which revealed that the device was broken.The device history records (dhr) were reviewed for all available lot numbers; the devices were 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.The investigation into the cause of the reported problem was not able to confirm the failure mode of chemical indicator failed to transition to its post sterilization color.However, the issue likely occurred due to the device being used after its expiration date.

• Brand Name: INSERTER SHAFT
• Common Device Name: INSTRUMENTS SPINAL MOTION
• 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: 12303014
• Report Number: 2916714-2021-00150
• Device Sequence Number: 3531802
• Product Code: LXH
• UDI-Device Identifier: 04046964985119
• UDI-Public: 4046964985119
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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 Model Number: ME246R
• Device Catalogue Number: ME246R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown