MAUDE Adverse Event Report: AESCULAP AG LEMPERT BONE RONGEUR CVD 200MM; BASIC INSTRUMENTS

Model Number FO451R

Device Problem Break (1069)

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

Event Date 06/04/2019

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 lempert bone rongeur.During a podiatry procedure, the instrument broke after using it to pull articular cartilage out of a joint.The instrument and piece was removed easily; it was noted that piece had not broken off near the patient's surgical incision.There was no patient harm but the malfunction caused a 3 minute surgical delay.Another device was used instead and the case was completed successfully.

Manufacturer Narrative

D4: lot # h4: manufacture date manufacturing evaluation: the instrument arrived with the broken off part in a decontaminated condition and it is available for investigation.Investigation - we made a visual inspection of the instrument.Here we found grooves and visible damage.Additionally we made an optical inspection of the fracture surface.Here we found dark brown discoloration and a mixed fracture with signs of an inter-crystalline and trans-crystalline fracture.We made a visual inspection of the broken off part.Here we found a second area at the surface of the jaw and grooves.Furthermore we made an optical inspection of the fracture surface.We also detected dark brown discoloration and a mixed fracture with signs of an inter-crystalline and trans-crystalline fracture.Additionally, the production department could not find any manufacturing errors and the cut is checked twice at 100%.Furthermore, regarding orientation measurement to check the hardness of the instrument; according to specifications, it is in the allowable tolerance.Batch history review - the device quality and manufacturing history records have been checked for the lot number and found to be according to the 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 a reprocessing related.Rationale - according to the quality standard and history files, a material defect and production error can be excluded.Investigations lead to appearance that the breakages were caused by mechanical overload situation and a stress-corrosion cracking.It appears that the dark brown discolorations are signs of an old crack.There is the possibility for a mechanical overload situation and this led to a crack.Due to the existing pre-damage or weak point, the reprocessing was fracture-triggering.A mechanical overload situation by cutting or something else like that led then to the breakage.The grooves at the jaw were caused by grinding process.Regarding the statement of the production department, the cut is checked and therefore the cutting performance met the specifications at delivery.The grooves at the male box-lock could have been caused due to insufficient lubrication or foreign bodies.Furthermore, according to the instructions for use (ifu), the following caution must be observed: - "damage (metal seizure/friction corrosion) to the product caused by insufficient lubrication - - prior to function checks, lubricate moving parts with maintenance oil suitable for the respective sterilization process (e.G.For steam sterilization: aesculap sterilit oil spray jg600 or sterilit drip lubricator jg598).".

• Brand Name: LEMPERT BONE RONGEUR CVD 200MM
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8744449
• MDR Text Key: 149512228
• Report Number: 9610612-2019-00425
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FO451R
• Device Catalogue Number: FO451R
• Device Lot Number: 4510478467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Distributor Facility Aware Date: 06/04/2019
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1