MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURSTRSERR 2X12MM185MM

Model Number	FF562R
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer 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 inc.That a caspar rongeurstrserr 2x12mm185mm (part # ff562r) was used during an unknown procedure performed on (b)(6) 2021.According to the complainant, during the procedure, a piece of the instrument broke away and detached into the patient.The fragment was retrieved under flouroscopy.The complaint device was available to be returned to the manufacturer for evaluation.No patient complications were reported as a result of the fragment retrieval.Although requested, additional information has not been made available.The adverse event / malfunction is filed under aag reference xc (b)(4).
Event or Problem Description
Update: the following additional information was received via mw5100488: the event date was noted as (b)(6) 2021 (previously reported as (b)(6) 2021).The malfunction occurred during an l3-s1 laminectomy procedure.No harm to patient and no surgical delay.
Event or Problem Description
No updates required.
Additional Manufacturer Narrative
Manufacturer site evaluation: the complaint device was returned to the manufacturer for evaluation.A visual examination was performed which found that the jaw had broken off.A deformation to the jaw hinge was identified.Additionally, an optical inspection of the fracture surface for the broken off jaw was performed.No anomalies or deviations were identified.The device history records (dhr) were not able to be reviewed as no lot number was made available.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.The investigation into the cause of the reported problem was able to confirm the failure mode.The device jaw had broken away.Although a root cause was not able to be identified, the investigation determined that there was no indication for a material-, manufacturing- or design-related failure.

• Brand Name: CASPAR RONGEURSTRSERR 2X12MM185MM
• Common Device Name: RONGEUR
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11739637
• Report Number: 2916714-2021-00064
• Device Sequence Number: 11520428
• Product Code: HTX
• UDI-Device Identifier: 04038653044153
• UDI-Public: 4038653044153
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2021
• Report Date (Section F): 04/28/2021

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: FF562R
• Device Catalogue Number: FF562R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/16/2021; 10/29/2021
• 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
• Date Report Sent to FDA: 04/28/2021