MAUDE Adverse Event Report: SYNTHES MONUMENT EXPERT HN Ø7 CANN L250 TAN

Catalog Number 04.001.230S

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem Tissue Damage (2104)

Event Date 01/20/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: on (b)(6) 2014, expert humerou nail (ehn) system was used for a right humeral diaphyseal fracture case.The surgeon tried to insert a guide rod into the fracture site first, but could not.The surgeon tried to insert the guide rod using synream reaming system.However, the surgeon inserted the reduction tool into the medullary cavity without the reamer head.As a result, the reduction head was left in the medullary cavity.The reduction head was removed after making an incision in the fracture site.The fracture site was reduced with the forceps, and then normal nail insertion was done.The fixation was completed with 2 proximal screws and 2 distal screws.Two (2) days after the operation, the patient was diagnosed with suspected radial paralysis.This report is on the nail.This is 1 of 6 reports for complaint (b)(4).

Manufacturer Narrative

This device used for treatment and not diagnosis.Synthes (b)(4) manufactured the 7mm cannulated humeral nail, p/n 04.001.230s, lot # 6879120 (supplier lot # 18132198), per work order (b)(4), originated on february 09, 2012, for 6 parts.The lot was processed per specification requirements, inspected, and conformed to the synthes in-process inspection (b)(4).There were no mrrs, ncrs, or complaint-related issues for this lot.6 parts were released to the warehouse on february 10, 2012.The investigation could not be completed; no conclusion could be drawn, as no product was received.Placeholder.

• Brand Name: EXPERT HN Ø7 CANN L250 TAN
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: sherry laing ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3636985
• MDR Text Key: 4178592
• Report Number: 1719045-2014-00109
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/22/2014

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: Health Professional
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: 04.001.230S
• Device Lot Number: 8132198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2012
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 74