MAUDE Adverse Event Report: AESCULAP AG SYPERT BONE RONGEUR 8/360MM; BONE RONGEURS AND BONE CUTTING FORC

Model Number FG052R

Device Problems Failure to Cut (2587); Device Operates Differently Than Expected (2913)

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

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).In order to create space for the blood vessels and nerves between the first rib and clavicula the first rib had to be removed.First step is to cut the first rib (a piece) with a bone cutting forceps, second step is to make the sharp edges as a result of cutting less sharp in to prevent stabbing through the pleara viscerale which can cause a pneumothorax, or stabbing through the blood vessels or nerves.For this second step the fg052r is supposed to bite small bits from the sharp edges without using to much pressure because to much pressure can cause the rib to shatter or splinter which is exactly what happened.A splinter punctured the pleura viscerale.To prevent a pneumothorax after surgery the or team placed a small thoraxdrain.The fg052r was delivered on 8 may and used for the first time.The initial feedback on 8 may (no complaint) only stated the fg052r being blunt.The complaint was received (b)(6) may.Unfortunately in between this dates the fg052r was being cut by our instrument repair department.The surgeon who submitted the complaint tried the same fg052r after it was cut with the same result.It does not cut without a lot of pressure which only leaves the question i think if the double hinge creates enough leverage.

Manufacturer Narrative

Investigation: the investigation was performed using a keyence vhx-5000 digital microscope.On the rear part of both jaws, blunt areas can be found, which may be the cause of the need for higher force.Nevertheless, a functional test was successfully carried out.An additional "(b)(6)" stamp can not be found on the surface of the instrument.Batch history review: the device quality and manufacturing history records have been checked for all the available lot numbers, and been found to be according to specification valid at the time of production.No similar incidents have been filed with products from this batch.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.Rational: apart from the blunt rear ends of the blades, the instrument is according to the specifications.The blunt rear ends are most likely caused by wear and tear.It is possible that the instrument has been applied in an incorrect angle or position, which has caused the splinter of the bone.No capa is necessary.

• Brand Name: SYPERT BONE RONGEUR 8/360MM
• Type of Device: BONE RONGEURS AND BONE CUTTING FORC
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7635751
• MDR Text Key: 112453086
• Report Number: 9610612-2018-00254
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG052R
• Device Catalogue Number: FG052R
• Device Lot Number: 4509212949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/11/2018
• Device Age: 5 MO
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other