MAUDE Adverse Event Report: SYNTHES GMBH UNK - END CAPS: PFNA-II; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient was treated with the (b)(6) proximal femoral nail anti-rotation (pfna) nail for a fracture of the trochanteric femur from (b)(6) 2021 after falling down at home.A secondary fracture occurred under the (b)(6) pfna nail.The patient underwent a revision surgery to remove the (b)(6) pfna nail and replace it with a trochanteric fixation nail advanced (tfna) long nail on (b)(6) 2022.The femur was deformed outward due to the effect of the osteoporosis medication, so that the stress was concentrated at the point where the fracture occurred after the fall.This report is for an unknown end cap.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

Exact date of event is unknown; event occurred sometime between implantation in (b)(6) 2021 and explantation on (b)(6), 2022.This report is for an unknown end cap/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date is an unknown day in (b)(6) 2021.Initial reporter is a synthes sales representative.Device is not distributed in the united states, but is similar to device marketed in the usa.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.

• Brand Name: UNK - END CAPS: PFNA-II
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13941405
• MDR Text Key: 288363252
• Report Number: 8030965-2022-02019
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PFNA-II Ø12 XS 125° L170 TAN; UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention