MAUDE Adverse Event Report: AESCULAP AG SHANK LONG F/RECIP.SAW BL.GC615R/GC633R; HIGHSPEED POWER SYSTEMS

Model Number	GP569R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with gp569r -shank long f/recip.Saw bl.Gc615r/gc633r.According to the complaint description, the break occurred during the use.All the part were removed.There is no consequence for the patient.They once again encountered a problem with a saw blade holder when it was sterilised in a bag.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).
Event or Problem Description
Additional information: an additional medical intervention was necessary.Therefore this event was reevaluated and reportable as adverse event.
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint 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.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: SHANK LONG F/RECIP.SAW BL.GC615R/GC633R
• Common Device Name: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11399290
• Report Number: 9610612-2021-00129
• Device Sequence Number: 16990220
• Product Code: HBE
• UDI-Device Identifier: 04046964776083
• UDI-Public: 4046964776083
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: GP569R
• Device Catalogue Number: GP569R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/27/2021
• 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