MAUDE Adverse Event Report: AESCULAP AG CASPAR OSTEOPHYTE RONGHV-DTY3MM180MM; RONGEURS

Model Number	FF856R
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
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.
Event or Problem Description
It was reported that there was an issue with ff856r - caspar osteophyte ronghv-dty3mm180mm.According to the complaint description, the item is broken (incident).It occurred during a cervical procedure and there were no broken pieces.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).
Additional Manufacturer Narrative
Updated d4: lot number.Updated d9: date device returned to manufacturer.Updated h4: device manufacturing date.Updated h6: codes.Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: products available for investigation in a decontaminated condition.Vigilance investigator carried out the pictorial documentation visually and microscopically.All three rongeurs are cracked on the joint of the jaw with the shaft.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.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 2(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.Based upon the investigations results a capa is not necessary.

• Brand Name: CASPAR OSTEOPHYTE RONGHV-DTY3MM180MM
• Common Device Name: RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11309017
• Report Number: 9610612-2021-00140
• Device Sequence Number: 16435427
• Product Code: HTX
• UDI-Device Identifier: 04038653164523
• UDI-Public: 4038653164523
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: FF856R
• Device Catalogue Number: FF856R
• Device Lot Number: 4512037265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1