MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIP.MARYLAND DISS.FEN.5/310MM; BIPOLAR REUSABLE INSTRUMENTS

Model Number	PM438R
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with pm438r - jaw ins.Bip.Maryland diss.Fen.5/310mm.According to the complaint description, the hinge on the working end was broken during surgery.During the operation, suddenly only one of the jaws at the tip broke.The debris was collected immediately, and there were no abnormalities in the progress of the operation or the patient's condition.There was no described patient harm.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Involved components: pm600201 - metal inner tube 31cm.
Additional Manufacturer Narrative
Updated h4: manufacturing date updated h6: codes 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: the instrument provided is in a used condition, one of the jaw parts is broken off, the shaft is slightly bent.Vigilance investigator carried out the pictorial documentation visually and microscopically.The analysis of the fracture pattern illustrated a forced fracture due to overload e.G.Leverage or torsion during application or reprocessing.No pores, inclusions or foreign bodies could be found on the point of rupture.To avoid damages to the instrument, ifu must be observed.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 2(5)) according to din en iso (b)(4) 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.
Event or Problem Description
Involved components: pm600201 - metal inner tube 31cm.

• Brand Name: JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
• Common Device Name: BIPOLAR 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: 11806408
• Report Number: 9610612-2021-00366
• Device Sequence Number: 3535109
• Product Code: HGI
• UDI-Device Identifier: 04038653322862
• UDI-Public: 4038653322862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K003608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: PM438R
• Device Catalogue Number: PM438R
• Device Lot Number: 62338453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PM600201 - METAL INNER TUBE 31CM.; PM600201 - METAL INNER TUBE 31CM.
• Patient Sex: Unknown