MAUDE Adverse Event Report: AESCULAP AG DIETER MALLEUS NIPPER UP-CUT 75MM; OTOLOGY

Model Number OG300R

Device Problem Material Fragmentation (1261)

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

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 og300r - dieter malleus nipper up-cut 75mm.According to the complaint description, the stamps break intraoperatively.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00884 ((b)(4) + og300r).

Manufacturer Narrative

Additional information: d4-udi, h4 - manufacture date.Investigation results: visual investigation: the working ends of both devices are fractured.The footplates of both devices are fractured.The analysis of the fracture patterns illustrates forced fractures due to overload.No pores, inclusions or foreign bodies could be found on the points of ruptures.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 3(5) probability of occurrence 2(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 there is capa is not necessary.

• Brand Name: DIETER MALLEUS NIPPER UP-CUT 75MM
• Type of Device: OTOLOGY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10976960
• MDR Text Key: 221279003
• Report Number: 9610612-2020-00885
• Device Sequence Number: 1
• Product Code: JYR
• Combination Product (y/n): N
• PMA/PMN Number: A921718
• 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: 03/09/2021

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
• Device Operator: Health Professional
• Device Model Number: OG300R
• Device Catalogue Number: OG300R
• Device Lot Number: 4510505995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1