MAUDE Adverse Event Report: AESCULAP AG SHANK LONG F/RECIP.SAW BL.GC615R/GC633R; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	GP569R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
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 to aesculap ag that a shank long for reciprocating saw blade (part # gp569r) was used during an unknown procedure performed on (b)(6) 2021.According to the complainant, during the surgery, a piece of metal broke away and detached into the patient.The fragment was recovered from the patient.The complaint device was returned to the manufacturer for evaluation.No patient harm was reported as a result of the intervention.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the device has been analysed visually.The complained breakage of the spring can be confirmed.Furthermore, signs of usage can be found on the shank, randomly distributed.Due to its shape and form, the fracture surface could not be analysed in particular.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.Specially it is assumed that it came to an overload situation or pre damage during reprocessing.Based upon the investigations results a capa is not necessary.

• Brand Name: SHANK LONG F/RECIP.SAW BL.GC615R/GC633R
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11276326
• Report Number: 9610612-2021-00045
• Device Sequence Number: 14701841
• Product Code: HBE
• UDI-Device Identifier: 04046964776083
• UDI-Public: 4046964776083
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172709
• 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): 03/30/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 04/06/2021
• 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