MAUDE Adverse Event Report: BIOMET MICROFIXATION KELLY SCISSORS,STRAIGHT,16CM,6; SCISSORS, SURGICAL TISSUE, DENTAL

Model Number N/A

Device Problem Fracture (1260)

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

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported the tip fractured.There was no injury and no delay.The fractured pieces were removed.Additional information was requested but has not been received at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the scissors (part #51-0985, lot #unknown) showed signs of moderate wear.Upon inspection the instrument was found to be in decent overall condition with some discoloration and scratching due to normal wear.Both of the tips were fractured.There are no indications of manufacturing defects.Device history record (dhr) review was unable to be performed due to the age of the possible lots.Investigation results concluded that the reported event was due to the instrument experienced excessive force beyond what it was designed to encounter.The instructions for use (ifu) for general instrumentation has the following information provided in the section titled warnings and precautions: avoid undue stress or strain when handling or cleaning instruments.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Lot number and device manufacture date: there is no visible lot etch on the product.Potential lots that were sold to this customer are lot 425065 manufactured 12/16/1996, lot 511093 manufactured 2/16/1998, & lot 535127 manufactured 2/16/1998.

• Brand Name: KELLY SCISSORS,STRAIGHT,16CM,6
• Type of Device: SCISSORS, SURGICAL TISSUE, DENTAL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6834781
• MDR Text Key: 84243129
• Report Number: 0001032347-2017-00701
• Device Sequence Number: 1
• Product Code: EGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

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: N/A
• Device Catalogue Number: 51-0985
• Device Lot Number: SEE H10 NARRATIVE
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 08/10/2018
• 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: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention