MAUDE Adverse Event Report: AESCULAP AG RUSKIN BONE RONGEUR CVD 190MM; GENERAL SURGICAL INSTRUMENTS

Model Number FO518R

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 08/10/2020

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 a bone rongeur.According to the complaint description a screw was left in patient during surgery.During post-operative inspection it was discovered that a screw from bone rongeur was left inside the patient.The screw is approx.7mm x2mm large.It has been decided not to operate it out, due to the risk of major complications and infections.A fragement remained in situ.The adverse event is filed under aag reference 400483240 and 400486192.Associated medwatch-reports: 9610612-2020-00588 (400486192 + fo518r), 9610612-2020-00590 (400483240 + fo518r).

Event Description

Associated medwatch-reports: 9610612-2020-00588 ((b)(4) + fo518r); 9610612-2020-00590 ((b)(4) + fo518r).

Manufacturer Narrative

Investigation results: investigation of the devices was carried out visually.The provided rongeur are used, screws are loosened and stains and residues can be found on the surfaces.Rongeur #1: a screw is missing.The screw slots show signs od use.The working ends are heavily damaged.Rongeur #2: the screws are loosened.The screw slots show signs od use.The working ends are heavily damaged.The device quality and manufacturing history records (dhr) have been checked for the two available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot numbers with this error pattern.This type of screw connection is state of the art, but a loosening of the screw connection can never be excluded.Therefore, instruments must be inspected for loose, bent, broken, cracked, worn, or fractured components prior to use, as mentioned in the ifu.The damaged working end were most likely caused by overload situations due to improper usage, e.G.Cutting hard objects, like wire or something similar.Based on the dhr check we exclude a manufacturing related error.The root cause of the failure is most probably usage-related.Based on the investigations and results of the 8d report no capa is necessary.

• Brand Name: RUSKIN BONE RONGEUR CVD 190MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10579977
• MDR Text Key: 208336408
• Report Number: 9610612-2020-00590
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FO518R
• Device Catalogue Number: FO518R
• Device Lot Number: 4509456825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other