MAUDE Adverse Event Report: INNOVISION, INC. N-FORCE FC SCREW 4.0X35MM; SCREW, FIXATION

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem Loss of Range of Motion (2032)

Event Date 09/18/2013

Event Type  Injury  

Manufacturer Narrative

(b)(6).Medical product - n-force 4.0 2.7mm cann drill, cat#: in0171 lot#: ni (qty 2).N-force 4.0 1.4mm k-wire, cat#: in0211 lot#: ni (qty 3).Product is currently not expected to return to zimmer biomet for investigation as it remains implanted.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause is related to no countersink being available at the time of this procedure.The countersink was developed after 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.

Event Description

It was reported that during a trauma procedure, the surgeon stated that upon insertion of the screw, it sat proud on the patient's talus.After the procedure, the patient experienced range of motion issues.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: N-FORCE FC SCREW 4.0X35MM
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): INNOVISION, INC.; 1975 nonconnah blvd.; memphis TN 38132
• Manufacturer (Section G): INNOVISION, INC.; 1975 nonconnah blvd.; memphis TN 38132
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7259890
• MDR Text Key: 99595556
• Report Number: 0001056357-2018-00001
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2014
• Device Model Number: N/A
• Device Catalogue Number: IN00635FS
• Device Lot Number: 2012100950
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR