MAUDE Adverse Event Report: AESCULAP AG MIASPAS TL RONGEUR 6MM 320MM STR; RETRACTORS AND INSTRUMENTS

Model Number FF530R

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2020

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 miaspas tl rongeur.During a anterior lumbar interbody fusion (alif) the working end of the rongeur broke during use.The broken fragments were clearly visible and easily removed.All pieces were retrieved using a forceps.An additional medical intervention was necessary.There was no surgical delay.All available information has been provided.The adverse event is filed under reference (b)(4).

Event Description

No updates.

Manufacturer Narrative

Reference code (b)(4).Device name miaspas tl rongeur 6mm 320mm str.Serial number n/a.Batch number 52380998.Udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a unit of use udi-di (b)(4).Manufacturing date (b)(6) 2017.Investigation no product at hand.Pictorial documentation no product at hand.Batch history review the device quality and manufacturing history records (dhr) have been checked for all 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 number(s) with this error pattern.Explanation and rationale without the product, an exact cause cannot be determined at this moment.Based on the device history records and the complaint review, a material or production related error can be excluded most likely.Therefore at this stage of investigation, we assume that the root cause of the error is most probably usage relate (user notes are listed in the ifu).Corrective action according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.

• Brand Name: MIASPAS TL RONGEUR 6MM 320MM STR
• Type of Device: RETRACTORS AND INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10351068
• MDR Text Key: 205291662
• Report Number: 2916714-2020-00297
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF530R
• Device Catalogue Number: FF530R
• Device Lot Number: 52380998
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/30/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention