MAUDE Adverse Event Report: AESCULAP INC. MARTIN CARTILAGE SCISS CVD SERR 200MM; SCISSORS, ORTHOPEDIC, SURGICAL

Model Number	MB147R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as lot # of the device in question was not known.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
It was reported to aesculap inc.That a martin cartilage sciss cvd serr 200mm (part # mb147r) was used during a breast reconstruction performed on (b)(6) 2021.According to the complainant, during the procedure, while the surgeon was cutting tissue, the middle of the screw fell into the patient and half of the scissors right blade broke off.The surgeon was able to retrieve the screw in time, however, the case was delayed by approximately twenty (20) minutes.Reportedly, the surgeon was able to remove the screw and blade with pickups, and then the procedure was able to be continued and successfully completed using a different manufacturers device.No additional x-rays were required.The complaint device was not returned to the manufacturer for evaluation.The adverse event is filed under aag reference xc (b)(4); cc (b)(4).

• Brand Name: MARTIN CARTILAGE SCISS CVD SERR 200MM
• Common Device Name: SCISSORS, ORTHOPEDIC, SURGICAL
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 11859866
• Report Number: 2916714-2021-00077
• Device Sequence Number: 14293439
• Product Code: HRR
• UDI-Device Identifier: 04046964683589
• UDI-Public: 4046964683589
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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: MB147R
• Device Catalogue Number: MB147R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention