MAUDE Adverse Event Report: AESCULAP AG TC METZENBAUM SCISSORS CVD 180MM; BASIC INSTRUMENTS

Model Number	BC263R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.Upon examination of the scissors, a break in the tip of the scissors was found.The fragment is not provided for examination.Examination of the fracture surface revealed a fatigue fracture.No material defects such as pores or inclusions are found.This was most likely caused by a shortfall in dimensions during third-party preparation.Traces of reprocessing are clearly visible.The critical limit dimensions of 2.6mm ±0.2mm were clearly undercut.The actual dimension is 1.8mm.Furthermore, corrosion residues were found on the surface.Batch history review: due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 3(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results maintenance was improperly performed by third parties.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results, no capa is necessary.
Event or Problem Description
It was reported to aesculap ag that a tc metzenbaum scissors cvd 180mm (part # bc263r) was used during a shoulder replacement procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the tip of scissors broke off.The fragment was recovered from the patient and scans were performed to confirm that no fragments remained.The scans were negative.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.There was a surgical delay of less than 5 minutes.The adverse event is filed under aag reference (b)(4).

• Brand Name: TC METZENBAUM SCISSORS CVD 180MM
• Common Device Name: BASIC 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: 14311529
• Report Number: 9610612-2022-00123
• Device Sequence Number: 5224031
• Product Code: LRW
• UDI-Device Identifier: 04038653137817
• UDI-Public: 4038653137817
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

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: BC263R
• Device Catalogue Number: BC263R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown