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

Catalog Number	03.019.007
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 8030965-2022-00158
• Device Sequence Number: 5334123
• Product Code: HSB
• UDI-Device Identifier: 07611819425576
• UDI-Public: (01)07611819425576
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.019.007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRILLSL 10/3.8 F/03.019.013; UNK - NAILS: HUMERAL; UNK - SCREWS: TRAUMA; UNK- GUIDE ROD
• Patient Sex: Unknown