MAUDE Adverse Event Report: AESCULAP AG STERNUM SAW BL.RAPID ACT.35/75/0.7/0.9MM; POWER SYSTEMS

Model Number GC681R

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported to aesculap (b)(4) that a sternum saw bl.Rapid act.35/75/0.7/0 (part # gc681r) was used during a procedure performed on an unknown date.According to the complainant, the blade broke.The complant device has not been returned to the manufacturer for evaluation.There was no patient harm.Additional information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: as of the date of this report the complant product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (6(10)severity x 2(10)probability of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: based on the provided information and without a product for investigation, a clear conclusion cannot be drawn.Furthermore, there is no lot number available.Therefore, a review of the device history records must remain incomplete.According to the statistical analysis, there is no indication for a systematical product or manufacturing failure.Conclusion and root cause: a clear root cause conclusion cannot be drawn due to the non-availability of important information and the device itself.Corrective action: a capa is not necessary.

• Brand Name: STERNUM SAW BL.RAPID ACT.35/75/0.7/0.9MM
• Type of Device: POWER SYSTEMS
• 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: 13501707
• MDR Text Key: 288805746
• Report Number: 9610612-2022-00014
• Device Sequence Number: 1
• Product Code: DWH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GC681R
• Device Catalogue Number: GC681R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1