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

Model Number FK894R

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  Injury  

Event 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).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

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 Description

No changes required.

• Brand Name: KAIRISON SHAFT DET.UP 285MM 4MM
• Type of Device: PUNCH, SURGICAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12829418
• MDR Text Key: 280894433
• Report Number: 2916714-2021-00217
• Device Sequence Number: 1
• Product Code: LRY
• UDI-Device Identifier: 04046963329624
• UDI-Public: 4046963329624
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2021,03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 11/17/2021
• Distributor Facility Aware Date: 10/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention