MAUDE Adverse Event Report: AESCULAP AG DIETER MALLEUS NIPPER UP-CUT 75MM; GENERAL SURGICAL INSTRUMENTS

Model Number OG300R

Device Problem Break (1069)

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

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).It was reported that one of the instruments (dieter malleus nippe) broke.It was replaced which cause a 20-30 minute delay in surgery.The broken piece was retrieved.There was no harm to the patient reported.

Manufacturer Narrative

Investigation: the investigation was performed using a keyence vhx-5000 digital microscope.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 all available lot numbers.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch/these batches.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.Rational: this kind of instrument is designed for delicate use only.It is liable that a mechanical overload situation led to the breakage.The visual investigation indicated that the quality requirements are in the specified tolerance range.No capa is necessary.

• Brand Name: DIETER MALLEUS NIPPER UP-CUT 75MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6407542
• MDR Text Key: 70312667
• Report Number: 9610612-2017-00092
• Device Sequence Number: 1
• Product Code: JYR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OG300R
• Device Catalogue Number: OG300R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/20/2017
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: 02/15/2017
• Supplement Dates FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other