MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIP.MINI METZENBAUM SCIS.5/310MM; REUSABLE INSTRUMENTS

Model Number	PM437R
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 (b)(4) that a jaw ins.Bip.Mini metzenbaum scis.5/310mm (part # pm437r) was used during a procedure performed on an unknown date.According to the complainant, during the surgery, sparking was observed from the instrument.The complaint device will be returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.The blue ceramic is fractured.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.Furthermore, the shaft is slightly bent, also an indication for an overload situation.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 (severity4(5) probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures/preventive measures: the breakage of the ceramic was 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.MINI METZENBAUM SCIS.5/310MM
• Common Device Name: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12129480
• Report Number: 9610612-2021-00492
• Device Sequence Number: 3592140
• Product Code: GEI
• UDI-Device Identifier: 04038653305117
• UDI-Public: 4038653305117
• 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: PM437R
• Device Catalogue Number: PM437R
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 07/07/2021
• 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