MAUDE Adverse Event Report: SYNTHES GMBH 12.0MM MEDULLARY REAMER HEAD

Catalog Number 352.120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2024

Event Type  Injury  

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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10 therapy date: (b)(6) 2024.E1 initial report phone number:(b)(6).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 Description

Device report from synthes reports an event in germany as follows: it was reported that on (b)(6) 2024, during the procedure the synream shaft broke and the drill head remained in the medullary canal.The patient has histologically confirmed breast cancer with multiple osseous metastases.The right femur was markedly osteolytic with a considerable risk of fracture.On the opposite side on the left multiple metastases with risk of fracture.However, the bone substance was still sufficient here, so there was indication for nailless osteosynthesis.Entry into the operating room, lateral position, surgical disinfection and sterile disinfection of the operating field.Started with the left side for nail implantation.Presentation was under visualization control.Opening of the medullary canal, insertion of an intramedullary wire was performed.Control in 2 planes.Then reaming of the medullary canal was conducted.During reaming at 12 mm, the synream shaft broke off and the drill head remained in the medullary canal.Accordingly, the medullary canal needed to be opened through the knee and the reamer retrieved, as it could no longer be pulled out using the wire.The surgical team had to drill over the reamer, then knock it out with the nail inserted antegrade and then recovered the distal drill head.They then placed the nail in its final position and inserted the femoral lag screw in the center/center position.To do this, the femoral neck wire needed to be placed first.They drilled over of the femoral neck wire and inserted the nail.Static locking proximally was performed.They then drilled the distal locking under bv.Inserted the corresponding screw under bv, then irrigation of the situs both proximally and distally was performed.Layered proximal as well as distal.Layered wound closure of all access points.Sterile dressing was conducted.The surgery and anesthesia time was prolonged by the incident, and an additional surgical access was required.This report involves one (1) 12.0mm medullary reamer head.This is report 1 of 2 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

• Brand Name: 12.0MM MEDULLARY REAMER HEAD
• Type of Device: REAMER
• 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: 18987337
• MDR Text Key: 338720523
• Report Number: 8030965-2024-04152
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819243767
• UDI-Public: 07611819243767
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

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 Catalogue Number: 352.120
• Device Lot Number: F-24388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SYNREAM FLEXSHAFT; UNK - CABLE/WIRE; UNK - NAILS; UNK - SCREWS: LAG
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 95 KG