MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURSTRSERR 2X12MM160MM; BONE PUNCHES, RONGEURS

Model Number FF532R

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Investigation results: the investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq.-nr.2000024840) and the digital-camera "panasonic dmc tz8".The instrument arrived in a clean status with visible damage but without the broken off part.We made a visual inspection of the instrument.Here we found a deformed jaw hinge.Additionally we made an optical inspection of the fracture surface.No abnormalities were detected.The device quality and manufacturing history records have been checked for the lot number (4510207037) and found to be according to the specification valid at the time of production.No similar incidents have been filed with products from this batch.The root cause of the problem is most probably usage related.According to the quality standard and dhr files a material defect and production error can be excluded.No pores or foreign bodies could be found on the point of rupture.Investigations lead to the assumption that the breakage was caused by an improper handling due to a mechanical overload situation.There is the possibility of torsion or high leverage with the instrument.The deformed jaw hinge is an additional sign for a mechanical overload situation.

Event Description

It was reported that there was an issue with the product caspar rongeurstrserr 2x12mm160mm.The doctor claims that the jaw was broken during the operation.The broken part could be removed from the operation area.There was no patient harm.This malfunction prolonged the surgery for approx.30 minutes.The malfunction is filed under aag reference (b)(4).

• Brand Name: CASPAR RONGEURSTRSERR 2X12MM160MM
• Type of Device: BONE PUNCHES, RONGEURS
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9146116
• MDR Text Key: 176064120
• Report Number: 9610612-2019-00688
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF532R
• Device Catalogue Number: FF532R
• Device Lot Number: 4510207037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2019
• 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