MAUDE Adverse Event Report: AESCULAP AG DET.RONGEUR STANDARD 150UP 3.0/180MM; BONE PUNCHES, RONGEURS

Model Number	FH913B
Medical Device Problem Codes	Material Erosion (1214); Peeled/Delaminated (1454); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.(b)(4).
Event or Problem Description
It was reported that there was an issue with a rongeur.According to the complaint description the surface quality changed.After 9 times of preparation the coating dissolves and the surface condition has changed.There are also unevennesses in the material.Found prior to use.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00457 (b)(4), 9610612-2020-00459 (b)(4).
Additional Manufacturer Narrative
Investigation results: the device was available for investigation.The device history records have been checked for all available lot numbers and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot numbers.Based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage, and in case of the friction found on the sliding surface by insufficient lubrication.The signs of friction and scratches found on the surface/coating are signs for the contact of the surface with other instruments or other hard surfaces during the reprocessing or the usage of the rongeurs.Regarding the described issues with fibres coming from the gauze used for intra-operative cleaning we want to inform, that gauze is not suitable for such a cleaning, as edges coming from the geometry of the mouth are part of the design and are not avoidable.There is no indication for a material defect or manufacturing failure on the basis of the device history records.Based on the investigations and results of the 8d report no capa is necessary.
Event or Problem Description
The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00457 ((b)(4)- fh914b), 9610612-2020-00458 ((b)(4)- fh913b), and 9610612-2020-00459 ((b)(4)- fh912b).

• Brand Name: DET.RONGEUR STANDARD 150UP 3.0/180MM
• Common Device Name: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10480175
• Report Number: 9610612-2020-00458
• Device Sequence Number: 2630840
• Product Code: HTX
• UDI-Device Identifier: 04046964608414
• UDI-Public: 4046964608414
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/19/2020

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: FH913B
• Device Catalogue Number: FH913B
• Device Lot Number: 52564525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1