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

Model Number	OG300R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that a dieter malleus nipper up-cut 75mm (part # og300r) was used during a choleosteatome removal procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the instrument broke.Reportedly, the surgeon noticed a piece of metal in the ear.After retrieval, the fragment was determined to be from the og300r device.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.No adverse patient outcome was reported as a result of the event.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: visual investigation: the analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, includsions or foreign bodies could be found on the point of rupture.The breakage due to overload was probably favoured by a gradation that was milled too deep.The age of this batch indicates the old production status.We therefore assume that this is the same defect.Here it was found that the depth of the milled step was not always milled according to specifications and thus favoured breakage.This is documented in a q-notification.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results, the root cause is most probably manufacturing-related.A product safety case (psc) will be initiated.Any action regarding capa will be addressed with this case.

• Brand Name: DIETER MALLEUS NIPPER UP-CUT 75MM
• Common Device Name: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13792837
• Report Number: 9610612-2022-00071
• Device Sequence Number: 3733520
• Product Code: JYR
• UDI-Device Identifier: 04038653051588
• UDI-Public: 4038653051588
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OG300R
• Device Catalogue Number: OG300R
• Device Lot Number: 4511920715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown