MAUDE Adverse Event Report: AESCULAP AG KAIRISON SHAFT DET.UP 285MM 4MM; PUNCH, SURGICAL

Model Number	FK894R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a kairison shaft det.Up 285mm 4mm (part # fk894r) was used during a laminectomy decompression fusion procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the instrument tip broke off.Minimal intervention was required for piece retrieval.Reportedly a five (5) to ten (10) minute surgical delay occurred.The procedure was successfully completed using an alternate device.The complaint device was not returned to the manufacturer for evaluation.An additional medical intervention was required to retrieve the tip.The adverse event / malfunction is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
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 no lot number was 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
No changes required.

• Brand Name: KAIRISON SHAFT DET.UP 285MM 4MM
• Common Device Name: PUNCH, SURGICAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12829418
• Report Number: 2916714-2021-00217
• Device Sequence Number: 19172871
• Product Code: LRY
• UDI-Device Identifier: 04046963329624
• UDI-Public: 4046963329624
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/24/2022
• Report Date (Section F): 11/17/2021

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: FK894R
• Device Catalogue Number: FK894R
• Device Lot Number: 0621 OR CEO0123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 03/24/2022
• 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: 11/17/2021