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

Model Number OG300R

Device Problem Material Fragmentation (1261)

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

Event Date 02/09/2022

Event Type  Injury  

Event 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).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

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
• Type of Device: 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
• MDR Text Key: 287679952
• Report Number: 9610612-2022-00071
• Device Sequence Number: 1
• Product Code: JYR
• UDI-Device Identifier: 04038653051588
• UDI-Public: 4038653051588
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention