MAUDE Adverse Event Report: SYNTHES GMBH TRAUMA SYRING KIT 4*1 ML 2*2 ML; DISPENSER, CEMENT

Catalog Number 03.702.150S

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on unknown date, the patient underwent the initial surgery.After the initial surgery, the patient underwent the 1st revision surgery with tfna implants and cement for unknown reason on (b)(6) 2021.Both the initial surgery and the 1st revision surgery were performed at another hospital.It is not reported that the implants used in the initial surgery were our company¿s products.After the 1st revision surgery on (b)(6) 2021, it was found that non-union occurred and it led to shortening of shaft.In addition, the proximal bone fragment of the bone head cut out and the helical blade pierced the acetabulum.On (b)(6) 2022, the 2nd revision surgery was performed because infection also had occurred partially.In the 2nd revision surgery, tfna implants were removed, and cement beads were placed for the time being.The 2nd revision surgery was completed successfully with no surgical delay.The 3rd revision surgery via tha will be performed in the future.The surgeon stated that in the 1st revision surgery, the affected area seemed to be fixed with tfna implants with the bones remained displaced.No further information is available.This report is for one (1)trauma syring kit 4*1 ml 2*2 ml.This is report 4 of 4 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.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter name and address: (b)(6).Initial reporter occupation: reporter is a j&j sales representative.Postal code (b)(4).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.

• Type of Device: DISPENSER, CEMENT
• 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 ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15382226
• MDR Text Key: 299504838
• Report Number: 8030965-2022-06559
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 07611819476523
• UDI-Public: (01)07611819476523
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 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: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.702.150S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• 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
• Patient Outcome(s): Required Intervention