MAUDE Adverse Event Report: BIOMET TRAUMA TROCHANTERIC NAIL SH 11MMX22CM; ROD, FIXATION

Model Number N/A

Device Problem Difficult to Advance (2920)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Device requested, not yet received.

Event Description

During a procedure, the telescoping lag screw would not pass through the cephalic hole, resulting in a fracture in the patient's foot.No further information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

During a procedure, the telescoping lag screw would not pass through the cephalic hole, resulting in a fracture in the patient's foot.Another implant was used to complete the procedure.There was a 3 hour delay in the procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Visual review of the returned nail identified slight damage to the hole in which the lag screw is to be inserted.Visual review of the returned lag screw identified some slight damage to the threads, which likely occurred during the attempt to implant the device.A functional test was completed in which the lag screw was attempted to be assembled to the nail.The lag screw appeared to get caught on the outer sleeve during the test.After a closer analysis, the sleeve was coming into contact with the preassembled set screw.The set screw was backed out, and the functional test was attempted again.The device then functioned as intended and the devices were able to assemble together.Dhr was reviewed and no discrepancies were found.The root cause of the lag screw not assembling was related to the set screw in the nail being tightened down too far; however, it is unknown if the set screw was assembled incorrectly or the set screw was adjusted/moved after the nail was assembled.As such, no definitive root cause could be determined.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

This follow-up report is being submitted to relay additional information.Previous supplemental incorrectly reported that the reported event was not confirmed.Correction: complaint sample was evaluated and the reported event was confirmed.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: TROCHANTERIC NAIL SH 11MMX22CM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5850698
• MDR Text Key: 51268945
• Report Number: 0001825034-2016-02931
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: PK050118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• 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: 28811
• Device Lot Number: 134550
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• 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): Required Intervention
• Patient Age: 98 YR
• Patient Weight: 56