MAUDE Adverse Event Report: MEDACTA INTERNATIONAL, SA MPACT CALCELLOUS BONE SCREW 65 L 25 MM; FIXATION BONE SCREW

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Document review: mpact cancellous bone screw 6.5, 25mm: ref.(b)(4) - lot 130451 (205 screws produced).All parameters were found to be in accordance with the specs valid at the time of mfg, including washing and sterilization procedures.To date 106 screws were been already sold without any other similar issue.On the basis of the data collected, the event is likely not device related; the root cause is unk.

• Brand Name: MPACT CALCELLOUS BONE SCREW 65 L 25 MM
• Type of Device: FIXATION BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL, SA; castel san pietro ; SZ
• Manufacturer Contact: erin baumstark(c.o. medacta us ; strada regina 6874; castel san pietro ; SZ ; 3128782381
• MDR Report Key: 4420246
• MDR Text Key: 5378934
• Report Number: 3005180920-2014-00202
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K103721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1