MAUDE Adverse Event Report: AESCULAP INC 8.5 MM DETACHABLE TRIAL INSTRUMENT; INSTRUMENTS SPINAL MOTION

Model Number	ME586R
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, the details will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with a detachable trial instrument.According to the complaint description, the trial was noted to be loose on the 8.5 mm spacer.The procedure was an anterior disc replacement (adr).The trial fell into the wound and was immediately retrieved; it was used again in the surgery.There was a delay of less than 30 seconds.The device will be available for return to the manufacturer.The adverse event is filed under reference xc (b)(4).
Event or Problem Description
Update: the customer does not think there is anything wrong with the part but rather, the trials may be worn which could be why they are not holding well.
Additional Manufacturer Narrative
Investigation: the device was returned for investigation/evaluation of the failure of this part.The part was transferred to the quality department for inspection.The part was inspected visually as well as the dimensions that are in direct contact with the mating tool.The dimensions checked were the length of the pocket, the width of the pocket, the radius inside the pocket, the thread and the depth of the thread.Original manufacturer has completed its incoming inspection and found no evidence of any lack of dimensional integrity for this part.

• Brand Name: 8.5 MM DETACHABLE TRIAL INSTRUMENT
• Common Device Name: INSTRUMENTS SPINAL MOTION
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 11778879
• Report Number: 2916714-2021-00078
• Device Sequence Number: 3647258
• Product Code: LXH
• UDI-Device Identifier: 04046964920523
• UDI-Public: 4046964920523
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: D171172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: ME586R
• Device Catalogue Number: ME586R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention