MAUDE Adverse Event Report: ZIMMER BIOMET, INC. WSHRLC FIX 18MM W/4 EXT SPIKES; FASTENER, FIXATION

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 908438 washerloc tissue fixation 18mm 528380, 908842 42mm 6mm cancellous screw 361330.Customer has indicated that the product will not be returned to zimmer biomet for investigation, discarded.The investigation is in process.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: 0001825034-2019-00222, 0001825034-2019-00226.

Event Description

It was reported that during an acl/mcl fixation repair procedure, the tibial bone fractured, and open reduction and internal fixation was used to repair the fracture and complete the procedure.A delay of 30 mins was noted.No additional information is available at this time.

Manufacturer Narrative

The following report is being submitted to relay additional information received: the complaint was confirmed based on the operative record provided stating found fracture of tibia through the drill hole that extended up into tibia bone plug harvest site and out the lateral cortex.Review of the device history records identified no related deviations or anomalies.Use error is a possible cause due insufficient quality/quantity of bone but this cannot be confirmed; therefore, root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information is available to report at this time.

• Brand Name: WSHRLC FIX 18MM W/4 EXT SPIKES
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8275046
• MDR Text Key: 134010042
• Report Number: 0001825034-2019-00225
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K981967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 908468
• Device Lot Number: 624150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR