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

Model Number FF530R

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

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.According to the complaint description the device broke during surgery.During a anterior lumbar interbody fusion the working end of the rongeur broke during use.The broken fragments were clearly visible and easily removed.All pieces were retrieved.An additional medical intervention was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Product has not been received for investigation.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.Upon the product received we will report additional results in a supplemental report.

• 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: 10351060
• MDR Text Key: 202197766
• Report Number: 9610612-2020-00343
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention