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

Model Number FO518R

Device Problem Detachment of Device or Device Component (2907)

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

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 had been left in patient during surgery.There was concern that loosening of the screws might occur on similar instruments.Due to this issue, all four rongeurs were removed from the hospital as a precautionary measure and replaced.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00590 (400483240 + fo518r): a fragement remained in situ.

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.

Event Description

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

• 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: 10579975
• MDR Text Key: 208416748
• Report Number: 9610612-2020-00588
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FO518R
• Device Catalogue Number: FO518R
• Device Lot Number: 4510957990
• 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