MAUDE Adverse Event Report: AESCULAP AG ABC SCREW DRIVER F/SELF-LOCKING SCREWS; SCREWDRIVER

Model Number	FJ910R
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap inc.That a abc screwdriver f/self-locking screws (part # fj910r) was used during an anterior cervical discectomy and fusion (acdf) procedure performed on (b)(6) 2019.According to the complainant, the screwdriver tip became worn which prevented a secure fit with the screws.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).
Event or Problem Description
The malfunction is filed under aag reference 100027257/400499346.Occurred during surgery.Type of indication / operation was acde.No surgery delay.
Additional Manufacturer Narrative
Additional information: block h4.Corrected information: block d4 (lot #).

• Brand Name: ABC SCREW DRIVER F/SELF-LOCKING SCREWS
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11447870
• Report Number: 9610612-2021-00026
• Device Sequence Number: 3853080
• Product Code: HXX
• UDI-Device Identifier: 04038653449934
• UDI-Public: 4038653449934
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: FJ910R
• Device Catalogue Number: FJ910R
• Device Lot Number: 52416759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1