MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.019.024
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D2b: additional device product codes: hwc, hrs.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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 japan as follows: it was reported that on (b)(6) 2022, the patient underwent surgery to implant the multiloc humeral nail long for the humeral shaft.The surgery was completed successfully without any delay.Then, the removal surgery was performed on (b)(6) 2023 because bone union had been achieved.In the removal surgery, there was difficulty in removing the end cap, difficulty in connecting the extraction screw multiloc, and difficulty removing the nail with the connecting screw for multiloc.Attempts were made to remove the 15mm end cap in question, but the position of the end cap was over inserted by 10mm or more.As a result, the bone grew on the end cap and was difficult to remove.The surgeon used a bone chisel to scrape off bone and managed to extract the end cap, adding an additional 45 minutes of surgical time.After that, the surgeon tried to connect the extraction screw for multiloc in question, but the disk-shaped part in front of the connection part of the extraction screw became a stopper, making it difficult to connect with the nail.If connection was continued, a larger hole had to be made in order to connect, but the surgeon wanted to avoid this because the patient was young.The sales rep suggested using a multi-lock nail long insertion device for this removal, and shipped the device by charter shipment.The patient remained under anesthesia approximately 2.5 hours until the instruments arrived, and the operation resumed.The connecting screw for multiloc could be connected and the surgeon tried to remove the nail in question, but there was no sign of it coming off.Therefore, the combination hammer was connected and hammered by another hammer.The attempt was successful, and the nail was removed, but there was another extension of 45 minutes in the surgery.The scheduled surgery time was one hour, but it was extended by another four hours in total.This report involves one extraction screw for multiloc humeral nailing system.This report is related to (b)(4) , which reports the removal of the implants.This is report 1 of 1 for (b)(4).

• Brand Name: EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16852100
• Report Number: 8030965-2023-05504
• Device Sequence Number: 7529397
• Product Code: HSB
• UDI-Device Identifier: 07611819427242
• UDI-Public: (01)07611819427242
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120807
• 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: 03.019.024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MULTILOC HN Ø7 LE CANN L210 TAN
• Patient Sex: Unknown