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

Device Problem Device-Device Incompatibility (2919)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/21/2022

Event Type  Injury  

Manufacturer Narrative

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, but has yet to be received.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 (b)(4) reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent an open reduction internal fixation for trochanteric fracture of femur.The surgeon planned on using a 10 mm trochanteric fixation nail advanced (tfna) nail.However, due to the influence of the patient's bone quality and the entry point of the nail, it became difficult to insert the nail.The surgeon drilled the medullary cavity with a reamer for blades, but the nail could not be inserted.The nail was replaced with a 9-mm diameter nail and that was able to be inserted.The surgeon also had difficulty putting in the end cap.The surgery was completed with a less than thirty (30) minute delay and increased bleeding.The patient condition was reported stable.This report is for an unknown end cap.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - END CAPS: TFNA
• 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: 13560473
• MDR Text Key: 288205482
• Report Number: 8030965-2022-00997
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,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: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• 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: TFNA FEM NAIL Ø10 125° L170 TIMO15; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - REAMERS
• Patient Outcome(s): Required Intervention