MAUDE Adverse Event Report: AESCULAP AG CASPAR DRILL FOR DISTRACTION PINS; BIT, DRILL

Model Number	FF908R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a caspar drill for distraction pins (part # ff908r) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the surgical procedure, the drill tip broke off in the cervical vertebrae.An x-ray with c-arm was taken to confirm that the broken drill bit was in the vertebral body.The physician was able to successfully retrieve the broken bit from the bone.The procedure was then successfully completed using another of the same device.Reportedly, a surgical delay of approximately ten (10) minutes occurred.The complaint device has been returned to the manufacturer for evaluation.An additional medical intervention was performed.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: a visual examination of the device was performed.Which revealed, the typical signs of an intergranular fracture, most probably caused by mechanical overstress/overload.Batch history review: due to the fact that no lot number was provided, a review of a device history records for the complained device was not possible.Conclusion and measures / preventive measures: based upon the investigation results, a clear root cause conclusion cannot be drawn.There is no indication for a material manufacturing or design-related failure.Based upon the investigations results, no capa is necessary.
Event or Problem Description
No changes required.

• Brand Name: CASPAR DRILL FOR DISTRACTION PINS
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12096108
• Report Number: 2916714-2021-00122
• Device Sequence Number: 4752015
• Product Code: HTW
• UDI-Device Identifier: 04038653085545
• UDI-Public: 4038653085545
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022
• Report Date (Section F): 06/30/2021

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: FF908R
• Device Catalogue Number: FF908R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 05/25/2022
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/30/2021