MAUDE Adverse Event Report: AESCULAP AG KERRISON DETACH.130DEG UP 200MM 3MM THIN; BONE PUNCHES, RONGEURS

Model Number	FK963R
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (b)(4) (part # fk963r) was used during a procedure performed on (b)(6) 2021.According to the complainant, the device tip was curled up/bent, following use.The complaint device was available to be returned to the manufacturer for evaluation.No patient harm was reported as a result of this event.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: leading device: reference code (b)(4).Device name kerrison detach.130deg up 200mm 3mm thin.Serial number.Batch number 52615085.Manufacturing date 10.09.2020.Product is available for investigation in a decontaminated condition.Failure description: the kerrison punch shows a bent-up cutting edge on the upper slider part.Vigilance investigator carried out the pictorial documentation visually and microscopically.The punch shows a deformation on the cutting edge of the upper slider, which is bent-up in.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.There are no similar complaints against the same lot number with this error pattern.Explanation and rationale: the failures found in our investigation are clear signs of an overload situation during the procedure itself.We were not able to detect any hint for a material defect or a production error.Conclusion and root cause: due to the current deviation and according to the explanation and rationale, the root cause of the problem is most probably usage-related.A capa is not necessary.

• Brand Name: KERRISON DETACH.130DEG UP 200MM 3MM THIN
• Common Device Name: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11308943
• Report Number: 9610612-2021-00083
• Device Sequence Number: 14298716
• Product Code: GXJ
• UDI-Device Identifier: 04038653436880
• UDI-Public: 4038653436880
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/08/2021

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: FK963R
• Device Catalogue Number: FK963R
• Device Lot Number: 52615085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1