MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURSTRSERR 2X12MM185MM

Model Number FF562R

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event 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 (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: the product arrived in a clean status with a broken off jaw.We made a visual inspection of the product.Here we found a deformed hinge of the jaw.Additionally we made an optical inspection of the broken off jaw and of the fracture surface.No anomalies or deviation could be detected.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material, manufacturing or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: CASPAR RONGEURSTRSERR 2X12MM185MM
• Type of Device: RONGEUR
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11734992
• MDR Text Key: 262537002
• Report Number: 9610612-2021-00339
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 04038653044153
• UDI-Public: 4038653044153
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention