MAUDE Adverse Event Report: AESCULAP AG MICRO HOOK SEMI SHARP STR.230MM; MICRO INSTRUMENTS

Model Number	FD330R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User facility mdr id (b)(4).Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were not able to be reviewed as the lot number was not made available.However, 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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
It was reported to aesculap ag that two micro hook semi sharp str.230mm (part # fd330r) were used during an anterior cervical discectomy and fusion (acdf) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the tip of a nerve hook instrument broke off.The tip was retrieved, and the procedure was continued.A second nerve hook instrument (ref.Mdr id (b)(4)) was used, but the same issue recurred; the tip broke off.Although the tip of the first device was able to be retrieved, the second tip was not able to be located.X-rays were performed, but the tip was not identified.The complaint devices have not been returned to the manufacturer for evaluation.Additional information was provided which revealed the following, "the tip broke twice in the same case, during the part of the surgery where the ligament is lifted (standard technique), prior to reaching the dura.The first time it broke, the fragment was retrieved.The second time, it was not retrieved, possibly removed by the suction device.No kerrison was involved in the breakage, the hooks broke under tension during a standard surgical step.A different type of nerve hook was used to successfully complete the procedure.The patient's was reported to be "doing well" after surgery.A surgical delay of fifteen (15) to twenty (20) minutes was noted.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2022-00031 (400543708 + fd330r) - second breakage.

• Brand Name: MICRO HOOK SEMI SHARP STR.230MM
• Common Device Name: MICRO INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13549385
• Report Number: 9610612-2022-00032
• Device Sequence Number: 5059562
• Product Code: GDG
• UDI-Device Identifier: 04038653160396
• UDI-Public: 4038653160396
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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: FD330R
• Device Catalogue Number: FD330R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female