MAUDE Adverse Event Report: AESCULAP AG CUTTING PLIER F/WIRE 470MM; GENERAL SURGICAL INSTRUMENTS

Model Number LX164R

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the cutting plier.During an unspecified procedure, a portion of the cutting edge was broken off.It occurred when the instrument was being used to cut metal (bolt/rod).A surgical delay of 8 minutes was noted.An x-ray was taken to confirm that all pieces had been retrieved and none remained in the surgical field.Additional information was not provided.

• Brand Name: CUTTING PLIER F/WIRE 470MM
• 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: 8541703
• MDR Text Key: 144971091
• Report Number: 9610612-2019-00282
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LX164R
• Device Catalogue Number: LX164R
• Device Lot Number: 4510196471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/17/2019
• Date Manufacturer Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1