MAUDE Adverse Event Report: SYNTHES GMBH CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 03.019.007

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

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, the patient underwent open reduction internal fixation surgery for surgical neck fracture of the humerus. Before the surgery, when the sales rep explained about the drill sleeve to a nurse, something like a blood clot came out of the drill sleeve. The drill sleeve was cleansed and re-sterilized. During the surgery, when the surgeon inserted a nail using a guide rod and passing the connecting screw into the nail, a blood clot came flying. The guide rod in the unclean area was cut, the connecting screw was removed, and the connecting screw was cleansed and sterilized again. The surgeon took advantage of the time that connecting screw was being re-sterilized to remove the ilium. However, the time for re-sterilization took longer than that, so there was a time when the procedure could not be proceeded. The surgery was completed within thirty (30) minutes delay. It is possible that this event was caused by an insufficient cleansing at another hospital that used the same products before. No further information is available. This report is for one (1) connecting screw/cannulated for multiloc humeral nail. This is report 1 of 1 for complaint (b)(4).

• Brand Name: CONNECTING SCREW/CANNULATED FOR MULTILOC HUMERAL NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13179731
• MDR Text Key: 289266782
• Report Number: 8030965-2022-00158
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• 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: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 03.019.007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 01/06/2022 Patient Sequence Number: 1

Treatment

DRILLSL 10/3.8 F/03.019.013; UNK - NAILS: HUMERAL; UNK - SCREWS: TRAUMA; UNK- GUIDE ROD