MAUDE Adverse Event Report: AESCULAP AG LOVE-GRUENWALD RONGEURSTR3X10MM180MM; BONE PUNCHES,

Model Number FF805R

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)

Event Date 01/10/2020

Event Type  Injury  

Manufacturer Narrative

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 love-gruenwald rongeur.According to the customer report: "during the removal (herniated disc), the middle grasping forceps in the intervertebral disc space break off.The broken-off part cannot be recovered immediately.Multiple rinsing of the intervertebral space with saline solution to remove remaining disc particles and mobilization of the metal fragment.X-ray control.The metal fragment is located in the cranial part of the intervertebral disc.Palpation of the intervertebral disc space with the nerve hook and further grasping forceps.There will be a small bleeding from the depths is detected which stops spontaneously.The tissue removed now isn't always typical for intervertebral discs.Further removal results in the rupture of a second (large) grasping forceps.The anterior fragment can now be retrieved directly.Another radiological check with a metal suction cup in the intervertebral disc space.It is shown that the suction cup has been advanced to a far retroperitoneal position, with a perforation of the anterior longitudinal ligament.The further search for the metal fragment is stopped.A final check for blood dryness is performed.An immediately performed computed tomography (ct) abdomen shows a small retroperitoneal bleeding, without arterial component.Air is shown retroperitoneally in front of the disc space l5/s1 left and right.There is also some intraperitoneal free air detectable, probably by puncture with the suction cup.Postoperatively transfer to the intensive care unit for observation.A revision surgery was necessary.Planned endoscopic recovery of the forceps fragment on (b)(6) 2020.The adverse event/malfunction is filed under (b)(4).Associated medwatch-reports: 9610612-2019-00944 ((b)(4) ff807r).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2019-00944 (400460627 ff807r) general information both rongeurs have been received for investigation and have been decontaminated.Failure description the upper mouth part of both rongeurs is broken off.The broken mouth part of ff807r has been sent in, too.Investigation vigilance investigator carried out the pictorial documentation visually and microscopically.During investigation the breakage surfaces of the broken mouth part from ff807r and the breakage surface on both instruments have been analysed.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Batch history review the products do not require batch management because those are repaired instruments; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale according to the investigation results a material defect and production error can be excluded.Based on the analysis of the breakage surface, it is most likely that the breakage was caused by an overload situation during the surgery.Such an overload situation can be contributed by wear and tear of the cutting edges, which causes that the forces needed to cut the tissue will be higher.Furthermore the structure of the tissue to be cut has a highly relevant influence on the overload situation.Therefore the ifu is advising that cutting edges need to be sharp enough and only soft tissue has to be cut with rongeurs.For harder tissue kerrison punches should be used.Corrective action according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: LOVE-GRUENWALD RONGEURSTR3X10MM180MM
• Type of Device: BONE PUNCHES,
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9728327
• MDR Text Key: 180167046
• Report Number: 9610612-2019-00955
• 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
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF805R
• Device Catalogue Number: FF805R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR