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

Model Number	PM438R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
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 ag that a jaw ins.Bip.Maryland diss.Fen.5/310mm (part # pm438r) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the jaw broke.A branch fell into the situs but could be recovered.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.Although requested, additional information has not been made available.The malfunction is filed under aag reference xc (b)(4).Involved components: pm450r - handle for bipolar instruments - lot unknown.Pm973r - insulated outer tube 5/5mm 310mm - lot unknown.
Additional Manufacturer Narrative
Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.The ceramic including one jaw part is fractured, the fragments were not provided for investigation.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.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.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 4(5) probability of occurrence2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: the breakage of the ceramic and the jaw were most likely caused by an overload situation during handling or reprocessing.Based upon the investigations results a capa is not necessary.

• 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
• MDR Report Key: 12159283
• Report Number: 9610612-2021-00502
• Device Sequence Number: 19761351
• Product Code: GEI
• UDI-Device Identifier: 04038653322862
• UDI-Public: 4038653322862
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: PM438R
• Device Catalogue Number: PM438R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PM450R - LOT UNKNOWN; PM973R - LOT UNKNOWN