MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - CEMENT; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Catalog Number UNK - BIOMATERIAL - CEMENT: TR

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent orif for trochanteric fracture with the product in question and tfna long without the sales rep attending, and the cement leaked near the neck.The patient was a 95-year-old female and had a 4-part unstable fracture.The surgeon performed the usual technique and inserted the blade slightly downward.The cement was then injected, and when 1.5 ml had been injected, the leakage of the cement was confirmed so the surgeon stopped to inject.It was within the joint, but did not seem to be just barely over the acetabulum.The surgery was completed successfully without any surgical delay.After the surgery, the patient is being rehabilitated with no problems under full load instructions.No further information is available.Concomitant device reported - unk - nail head elements: tfna helical blade (part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device.This report is for one (1) unk - biomaterial - cement this is report 1 of 1 for complaint (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.Report is for an unk biomaterial - cement /unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

• Brand Name: UNK - BIOMATERIAL - CEMENT
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15918798
• MDR Text Key: 308167371
• Report Number: 8030965-2022-10659
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - BIOMATERIAL - CEMENT: TR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• 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 - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
• Patient Age: 95 YR
• Patient Sex: Female