MAUDE Adverse Event Report: AESCULAP AG ENDOSCOPIC MYOMA FIXATION INSTRUMENT; REUSABLE INSTRUMENTS

Model Number	PL430R
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap (b)(4) that an endoscopic myoma fixation instrument (part # pl430r) was used during a total laparoscopic hysterectomy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, a 5 millimeter (mm) laparoscopic myoma screw broke leaving a fragment embedded in a uterine fibroid inside the patient.Snapped inside uterine fibroid.The shaft of the instrument was removed immediately and the broken piece of the screw was removed shortly after.The event happened toward the end of the procedure and luckily did not cause harm to the patient.Roughly 20 mins operating time was added to the procedure due to the need to retrieve the broken instrument and ensure all parts were removed.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under (b)(4) reference (b)(4).
Additional Manufacturer Narrative
Additional information - block a1, a2, a3, e1, e3.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 results: visual investigation: the instrument shows signs of tanning such as scuff marks and changes in colour of the plastic handle.The front spiral part of the instrument is broken off.The fracture surface of the instrument was visually examined.A tough bending force fracture was found, which can be attributed to an overload.A definitive fracture analysis is hardly possible, as the fracture surface of the missing broken part should also be considered.Batch history review: the device quality and manufacturing history records (dhr) will be checked for the leading device(s) lot number(s) from the quality coordinator of the production plant.The results of the review will be documented.If the review shows any conspicuities, the report will be updated and actions will be initiated.There are no similar complaint 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 1(5) according to din en iso 14971 is still acceptable.Explanation and rationale: based on the investigation results, no pores or inclusions could be found at the point of breakage.Conclusion and measures / preventive measures: based upon the investigation results, a clear root cause conclusion cannot be determined.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: ENDOSCOPIC MYOMA FIXATION INSTRUMENT
• Common Device Name: REUSABLE 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: 13125547
• Report Number: 9610612-2021-00794
• Device Sequence Number: 1580588
• Product Code: KNA
• UDI-Device Identifier: 04038653347957
• UDI-Public: 4038653347957
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K943603
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2022

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: PL430R
• Device Catalogue Number: PL430R
• Device Lot Number: 4512033988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 06/01/2022; 06/01/2022
• Initial Report FDA Received Date: 12/31/2021
• Supplement Report FDA Received Date: 12/31/2021; 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2020
• 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 Age: 51 YR
• Patient Sex: Female