MAUDE Adverse Event Report: BIOMET TRAUMA PEG SMOOTH 2.0MM X 20MM; FIXATION, NAIL

Model Number N/A

Device Problems Metal Shedding Debris (1804); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2015

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 availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.

Event Description

It was reported patient underwent a hip procedure on (b)(6) 2015.During the procedure, it was reported that the smooth peg did not lock with implant plate.When the surgeon tried to lock the peg and the plate, wear debris was generated.Some of the debris fell into the patient and the surgeon removed all that he could find.Another peg was used to complete 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.

Manufacturer Narrative

Product left conforming to print as there was no evidence that states otherwise.Root cause of the event was most likely attributed to misalignment of peg screw thread and plate thread, which lead to the cross threading resulting in the lead thread separating from the peg body.Based on these results the complaint is considered confirmed.

• Brand Name: PEG SMOOTH 2.0MM X 20MM
• Type of Device: FIXATION, NAIL
• 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: 5091618
• MDR Text Key: 26349473
• Report Number: 0001825034-2015-03984
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK090374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 12/08/2015

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 131212220
• Device Lot Number: 463340
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/29/2015; 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2015
• 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