MAUDE Adverse Event Report: BIOMET TRAUMA PTN PERITROCHANTERIC NAIL TELESCOPING LAG SCREW, KEYED; ROD, FIXATION

Model Number N/A

Device Problems Disassembly (1168); Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

There are warnings in the package insert that state that this type of event can occur: under precautions, it states that ¿loosening or migration of the implant¿ is a possible adverse effect.Root cause cannot be determined with the information provided.(b)(4).

Event Description

It is reported that the patient was experiencing pain two weeks post-implantation.It was discovered through radiographs that the lag screw had backed out of the nail.No revision has been reported to date.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional and corrected information.The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.X-rays review identified that there was an intramedullary nail within the proximal femur, extending from the greater trochanter to the proximal diaphysis.Proximally, the nail is locked by a bridging or lag screw and distally it is affixed with an interlocking smaller screw; hence, within specifications.X-rays identified minimal displacement.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after 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.

• Brand Name: PTN PERITROCHANTERIC NAIL TELESCOPING LAG SCREW, KEYED
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6188445
• MDR Text Key: 62793838
• Report Number: 0001825034-2016-05168
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 11/14/2017

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: 14-429307
• Device Lot Number: 490520
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: 11/14/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2016
• 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
• Treatment: BEAD TIP GUIDE WIRE(B)(4) LOT 848810; CALIBRATED DRILL (B)(4) LOT 820790; GUIDE PIN THREADED TIP 471453 LOT 215530; NAIL END CAP 14-457001 LOT 069440; TI-DBLE LEAD CORTICAL SCREW14-405026 LOT 261080
• Patient Outcome(s): Other
• Patient Weight: 56