MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.2/2.7 MM SOFT TISSUE GUIDE; INSTRUMENT TRAUMA

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(udi): n/a.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020-03345.Will be returned.

Event Description

It was reported that a 2.7 drill bit was involved along with a 2.0/2.7 double drill guide.The surgeon was holding the drill guide in his hand with 2.7 drill bit through the 2.7 hole and attached to drill.When the drill was fired to turn the drill bit in the guide testing before use in the patient the drill bit was lodged and stuck in guide.Drill bit seized immediately and broke.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g4, g7, h2, h3, h4, h6, h10 the event is confirmed with product received.Visual examination of the returned product/provided pictures identified the drill bit has broken off on both ends of the guide.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to design deficiency.A corrective action was initiated as a result of the investigation of this event.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.

Manufacturer Narrative

(b)(4).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.

Event Description

No further event information available at the time of this report.

• Brand Name: 2.2/2.7 MM SOFT TISSUE GUIDE
• Type of Device: INSTRUMENT TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10460780
• MDR Text Key: 205913862
• Report Number: 0001825034-2020-03220
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K173767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 233500004
• Device Lot Number: 516349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN DRILL BIT
• Patient Age: 21 YR
• Patient Weight: 113