MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: PFNA-II; ROD, FIXATION, INTRAMEDULLARY

Device Problems Device-Device Incompatibility (2919); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown pfna-ii nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a surgery to treat the trochanteric fracture, after insertion of the device, it was noted that proximal femoral nail antirotation (pfna)-ii blade could not be locked.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.This report is for one (1) unk - nails: pfna-ii.This is report 2 of 2 for complaint (b)(4).

Event Description

It was further reported that there is no allegation/malfunction of the pfna ii nail.

• Brand Name: UNK - NAILS: PFNA-II
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12283763
• MDR Text Key: 265398707
• Report Number: 8030965-2021-06449
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Patient Sequence Number: 1
• Treatment: PFNA-II BLADE L85 TAN