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

Model Number FF856R

Device Problem Fracture (1260)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with ff856r - caspar osteophyte ronghv-dty3mm180mm.According to the complaint description, the pituitary ronguer (3 total) have all broken in the same place.There was no described patient harm, but occured during cervical procedure(s).Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

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
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11294542
• MDR Text Key: 232380124
• Report Number: 9610612-2021-00091
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF856R
• Device Catalogue Number: FF856R
• Device Lot Number: 4511695091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1