MAUDE Adverse Event Report: SYNTHES GMBH TI STERNAL LOCKING STRAIGHT PLATE-12 HOLES; PLATE, FIXATION, BONE

Catalog Number 460.019

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

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

Event Date 06/20/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in australia as follows: it was reported on (b)(6) 2022, that the titanium sternal fixation system first time user , i instructed numerous times of the correct orientation of the emergency pin.I asked to see if it was correct and it was.After he bent the plate he inserted it incorrectly.He inserted a number of screws and i noticed he changed the orientation of the plate.I did tell him.He would not remove it and said it would not make a difference.Also would not insert the extra screw on either side ( 4 screws either side - only inserted 3 ) would not go into cartilage.There was no surgical delay.The procedure was successfully completed.This report is for one (1) sternal lock-pl 2.4 straig 12ho ti.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.: additional product codes: hwc and jdq.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.

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.H10 additional narrative: d10: concomitants added.Therapy date (b)(6) 2022.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.D1.

• Brand Name: TI STERNAL LOCKING STRAIGHT PLATE-12 HOLES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kate karberg ; eimattstrasse; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15051956
• MDR Text Key: 303177722
• Report Number: 8030965-2022-04966
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819796195
• UDI-Public: (01)07611819796195
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093772
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 460.019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• 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 - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA