MAUDE Adverse Event Report: SYNTHES GMBH 1.3MM TI LCKNG T-PLATE 3H HEAD/5H SHAFT-STERILE; PLATE, FIXATION, BONE

Catalog Number 04.130.152S

Device Problems Crack (1135); Material Discolored (1170)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: 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.

Event Description

It was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for the fracture of 5th metatarsophalangeal bone with the locking t-plate in question.During the surgery, the surgeon cut one of the three head holes, not the shaft part with a plate cutter.At that time, the plate cutter seemed to touch the hole in the center of the t-shape head holes of the locking t-plate, and it seemed that there was a slight discoloration and a crack.After the surgery, it was confirmed by x-ray that it was also cracked.The surgery was completed successfully without any surgical delay.There is no problem now, but there is a possibility that the product may break.The surgeon commented that the patient would be followed up and the weight-bearing period could be prolonged depending on the situation.The surgeon also asked whether the t-shaped head 3 holes can be cut or not with the plate cutter.Concomitant device reported: unknown plate cutter (part# unknown, lot# unknown, quantity 1).This report is for one (1) 1.3mm ti lckng t-plate 3h head/5h shaft-sterile.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.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: 1.3MM TI LCKNG T-PLATE 3H HEAD/5H SHAFT-STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12369762
• MDR Text Key: 268208952
• Report Number: 8030965-2021-07219
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819692008
• UDI-Public: (01)07611819692008
• Combination Product (y/n): N
• PMA/PMN Number: K150099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.130.152S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• Patient Sequence Number: 1
• Treatment: UNK - CUTTING INSTRUMENTS: TRAUMA; UNK - CUTTING INSTRUMENTS: TRAUMA; UNK - CUTTING INSTRUMENTS: TRAUMA
• Patient Age: 25 YR