MAUDE Adverse Event Report: SYNTHES GMBH 8.5MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.018.240S

Device Problem Use of Device Problem (1670)

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

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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 diaphyseal bone defect procedure, the 8.5mm multiloc humeral nail was inserted and length was lost due to bone loss.This left the nail exposed in the proximal area.The surgeon decided to drill this part of the nail to avoid discomfort for the patient.This report is for one (1) 8.5mm ti multiloc humeral nail right/cann/240mm-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 8.5MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/240MM-STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12453607
• MDR Text Key: 270829406
• Report Number: 8030965-2021-07635
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819516540
• UDI-Public: (01)07611819516540
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K120807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.018.240S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2021
• 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: UNK - END CAPS: MULTILOC HUMERAL NAIL; UNK - NAIL HEAD ELEMENTS: MULTILOC HUMERAL SCREW; UNK - SCREWS: NAIL LOCKING