MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURUP-BITESERR 3MM160MM; BONE PUNCHES, RONGEURS

Model Number FF543R

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the rongeur.During an unspecified procedure, the "little jaw" broke and fell inside the patient.The piece was retrieved; and there was a 5 minute delay in surgery.Intervention was not required and no patient harm occurred.Additional information was not provided.

Manufacturer Narrative

Batch # - 4503478402.Manufacturing date - 27may2011.Manufacturing evaluation - the instrument arrived with the broken off part in a decontaminated condition and was available for investigation.Visual and optical inspection - we found a visibly damaged screw slot.The fracture surface showed unknown deposits, discoloration, and signs of a transcrystalline fracture.Additionally, we discovered visible damage at the cutting edge.Furthermore, we made a visual inspection of the broken off part and found a visibly damaged cutting edge.The fracture surface also showed unknown deposits, discoloration, and signs of a transcrystalline fracture.Batch history review - the device quality and manufacturing history records have been checked for the lot number and found to be according to specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause - the root cause of the problem is most likely usage related.Rationale - according to the quality standard and device history records (dhr) files a material defect and production error can be excluded.Investigations lead to the appearance that the breakage and visible damage were caused by an improper handling due to a mechanical overload situation.Possibly the visible damaged cutting edge and also the breakage could have been caused by overloading, lateral forces, torsion, or high leverage with the instrument.There is also the possibility for pre-damage or similar due to previous surgeries.A mechanical overload situation led to the forced fracture.The secondary damages could have been caused due to coming into contact of two surfaces after the fracture.Possibly the visible damage of the screw slots was caused by disassembly for cleaning/disinfection.According to the instructions for use (ifu), this product should not be disassembed.It is cleaned and disinfected in a fully assembled condition.Furthermore, according to the ifu, the following points, warnings and caution must be observed: intended use - the rongeurs are used for the ablation of soft tissue (e.G.Intervertebral disc tissue, mucosa, ethmoidal cells, cell tissue, nucleus tissue, sequester material) in neurosurgery and spine surgery; the ronguers cannot be used for the ablation of bones or adjacent bone structures, for which purpose aesculap recommends using bone punches, because of their higher mechanical load capacity.Safe handling - prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components; do not use the product if it is damaged or defective; set aside the product if it is damaged; replace any damaged components immediately with original spare parts.Safe operation - always carry out a function check prior to using the product; use the rongeurs only for their intended use; do not cut or lever bones or adjacent bone structures; avoid overloading the jaws by tearing off, holding or levering tissue; avoid lateral forces on the jaws (do not twist them); do not use ronguers with blunt edges, but submit them for repair.Inspection, maintenance, and checks - after each complete cleaning, disinfecting, and drying cycle, check that the instrument is dry, clean, operational, and free of damage (e.G.Broken insulation or corroded, loose, bent broken, cracked, worn, or fractured components); check that the product functions correctly; immediately put aside damaged or inoperative product and send them to aesculap technical service (ats), see technical service; send in to have repaired product with blunt cutting edge, see technical service.

• Brand Name: CASPAR RONGEURUP-BITESERR 3MM160MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8689048
• MDR Text Key: 147727927
• Report Number: 9610612-2019-00385
• Device Sequence Number: 1
• Product Code: HTX
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF543R
• Device Catalogue Number: FF543R
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/17/2019
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1