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

Model Number BC263R

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 290948951
• Report Number: 9610612-2022-00123
• Device Sequence Number: 1
• Product Code: LRW
• UDI-Device Identifier: 04038653137817
• UDI-Public: 4038653137817
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention