MAUDE Adverse Event Report: AESCULAP AG HOUSE CURETTEDBL-ENDANG-CUPS1.5&1.8MM; GENERAL SURGICAL INSTRUMENTS

Model Number OG185R

Device Problem Break (1069)

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

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing 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 house curette.The tip of curette broke off into patient during use.Doctor was able to retrieve broken piece.This incident did not cause or contribute to serious injury or death or a delay in surgery.The type of procedure was open reduction internal fixation (orif) left scaphoid.No patient harm was reported.Additional information was not provided.The product problem is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing evaluation: the broken product is available for investigation, but not the broken off fragment.Failure description - one of the working ends is broken off, the fragment is not available for investigation.Investigation - vigilance investigator carried out the pictorial documentation visually1 and microscopically2.The remaining working end is bent.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.Batch history review - the device quality and manufacturing history records have been checked for the available lot number and found to be according to our specifications 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.Rationale - due to the bent working end and the fracture pattern the breakage was most likely caused by an overload situation, for example leverage during handling.A capa is not necessary.

• Brand Name: HOUSE CURETTEDBL-ENDANG-CUPS1.5&1.8MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9011080
• MDR Text Key: 175859522
• Report Number: 9610612-2019-00626
• Device Sequence Number: 1
• Product Code: FZS
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OG185R
• Device Catalogue Number: OG185R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1