MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI LCP(TM) T-PLATE 2 HOLES HEAD/7 HOLES SHAFT; PLATE, FIXATION, BONE

Catalog Number 447.351

Device Problems Break (1069); Defective Device (2588)

Patient Problems Loss of Range of Motion (2032); Non-union Bone Fracture (2369); Physical Asymmetry (4573); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2023

Event Type  Injury  

Event Description

Device report from germany reports an event as follows: it was reported that following an elbow procedure on july 4, 2023, the surgeon provided negative feedback for a 2.0 t plate for radial head fractures.They stated that "for mason type one and two fractures, the plate can be used.However, for mason type three fractures, especially with a comminuted zone in the neck, the plate is completely undersized." this report is for a 2.0mm ti lcp(tm) t-plate 2 holes head/7 holes shaft.This is report 1 of 1 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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

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.Product was not returned.Based on the information available, it has been determined that no corrective and 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: 2.0MM TI LCP(TM) T-PLATE 2 HOLES HEAD/7 HOLES SHAFT
• Type of Device: PLATE, FIXATION, BONE
• 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: 17309910
• MDR Text Key: 318952224
• Report Number: 8030965-2023-08678
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819157330
• UDI-Public: (01)07611819157330
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063049
• 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

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 447.351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• 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