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

Model Number GP569R

Device Problem Break (1069)

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

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.This is a similar device report, a similar device of the reported device was sold to us the reported device is not marketed in the us.

Event 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bl.Gc615r/gc633r.According to the complaint description, the intrument broke at the end of the surgery, during its withdrawn.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the spring shank has broken-off.The component has been analysed visually.The breakage of the spring can be confirmed.Furthermore, signs of usage can be found on the shank, randomly distributed (golden area, shaft, connection).The correct condition of the shank including the feather can be found.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.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.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.There is no indication for a design problem or systematic failure based on that data.A usage related failure, probably in combination with wear and tear cannot be completely excluded.It is also possible that it came to an overload situation or pre damaging during the reprocessing.Based upon the investigations results a capa is not necessary.

• Brand Name: SHANK LONG F/RECIP.SAW BL.GC615R/GC633R
• Type of Device: TOOLS FOR HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12040860
• MDR Text Key: 266231540
• Report Number: 9610612-2021-00464
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• PMA/PMN Number: K172709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GP569R
• Device Catalogue Number: GP569R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1