MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEUR UP-BITE 4MM 155MM; MICRO NEUROSURGICAL INSTR.

Model Number FF844R

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the instruments were not available for investigation.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.Rationale: according to the quality standard a material defect and production error can be excluded.Without the product we cannot determine the exact cause.There is the possibility for a usage error due to improper handling or mechanical overload situation by torsion or high leverage with the instrument.According to the intended use: indication: the aesculap ronguers are used to remove soft tissue (e.G.Intervertebral disc tissue, mucous membrane, ethmoidal cells, cell tissue, nucleus tissue, sequester) in neuro and spinal surgery.Contraindication: the dismountable aesculap rongeurs are not suitable for removing bone or adjacent bone structures! for this purpose, we recommend the use of bone punches that can withstand higher mechanical loads.Due to the provided information."the customer scraped the disc".There is the possibility that the instrument was not used for its intended purpose.There is also the possibility that during scraping the movable open jaw may have been broken by lateral forces due to an overload.Possibly the instruments have been used to lever or scrape bones or adjacent bone structures.If further investigations are required, the product should be provided for examination.Furthermore, according to the instructions for use (ifu) the following points and caution must be observed: caution - damage or destruction of the jaws due to overload!.

Event Description

It was reported that there was an issue with the caspar rongeur.During an unspecified procedure, two instruments broke; this occurred while scraping the disc.It was noted that the surgeon had not used the correct one and had to use a more resistant instrument.There was no delay in surgery.An x-ray was necessary in order to continue with the surgery.The breakage had been clean with only 1 piece separated.The piece from the devices was easily retrieved and removed.Additional information was not provided.Associated medwatches: 9610612-2019-00298, 9610612-2019-00274 (this report).

• Brand Name: CASPAR RONGEUR UP-BITE 4MM 155MM
• Type of Device: MICRO NEUROSURGICAL INSTR.
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8546313
• MDR Text Key: 143033797
• Report Number: 9610612-2019-00274
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF844R
• Device Catalogue Number: FF844R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/12/2019
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention