MAUDE Adverse Event Report: ZIMMER, INC. MILLER GALANTE II TOTAL KNEE SYSTEM BONE SCREW DRILL; KNEE INSTRUMENT

Model Number N/A

Device Problems Fracture (1260); Overheating of Device (1437)

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

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant product: nexgen im anterior/posterior sizing guide, catalogue # 00597800300, lot # 53617200.

Event Description

It is reported that during a knee procedure when the surgeon inserted the 3.2mm drill bit through the hole, the drill overheated and melted the drill bit into the hole.The patient did not retain any pieces.There was a reported 30 minute delay in the procedure and the procedure was completed with another device.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The sizing guide was returned for review.Visual inspection revealed that a portion of the 3.2mm drill bit remained seized in one of the guide holes.Visual inspection also revealed impaction damage along the shaft and flutes.The manufacture date of the drill is unknown as product was not fully returned and no lot information was provided.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no were trends identified.It was concluded that the cut guide left zimmer biomet conforming because it had a service life of approximately 19 years before the concern.The lot of the drill is unknown, as such, it is unknown whether or not the product left zimmer biomet conforming.The complaint is considered confirmed as the returned cut guide clearly had a section of the drill in one of the cut guide holes.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.

• Brand Name: MILLER GALANTE II TOTAL KNEE SYSTEM BONE SCREW DRILL
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6140771
• MDR Text Key: 61304941
• Report Number: 0001822565-2016-04502
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2017

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00512008500
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2017
• 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: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR