MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG REYNOLDS SUPERCUT SCISSORS 5 CVD TUNGSTEN CARBIDE

Model Number	P6845TC
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned scissors are in used condition with the tips broken off, apparently due to physical/environmental damage.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
This is #1 of 2 reports for two identical devices and events.The facility reported that when the surgeon was dissecting tissue on patient number 1, the tip of reynold scissors number 1 broke on one side of the jaw and fell into the surgical site.All the broken parts were recovered and the field was irrigated thoroughly.Subsequently, another instrument on the tray in the room was used.There was no patient injury and no delay in surgery.

• Brand Name: REYNOLDS SUPERCUT SCISSORS 5 CVD TUNGSTEN CARBIDE
• Common Device Name: SCISSORS
• Manufacturer (Section D): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 11972764
• Report Number: 8010168-2021-00002
• Device Sequence Number: 14494847
• Product Code: LRW
• UDI-Device Identifier: 10381780220596
• UDI-Public: 10381780220596
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2021

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: P6845TC
• Device Catalogue Number: P6845TC / AD 463-13-01
• Device Lot Number: 253236
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/10/2021
• 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