MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI LCP RADIAL HEAD RIM PLATE 2 HOLES-RIGHT; PLATE, FIXATION, BONE

Catalog Number 441.680S

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that, the patient underwent the open reduction internal fixation surgery for 4 parts radius fracture with the radial head rim plate in question.After the surgery, it was confirmed by x-rays that the bone fragment was dislocated.On august 4, the revision surgery will be performed replacing the implants.This report is for one (1) 2.4mm ti lcp radial head rim plate 2 holes-right.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.H3, h4, h6: part: 441.680s.Lot: 8l14163.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 29 april 2021.Expiration date: 01 april 2031.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part: 441.680.Lot: 89p2293.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: 2.4MM TI LCP RADIAL HEAD RIM PLATE 2 HOLES-RIGHT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12378033
• MDR Text Key: 268488626
• Report Number: 8030965-2021-07284
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819829879
• UDI-Public: (01)07611819829879
• Combination Product (y/n): N
• PMA/PMN Number: K040777
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 441.680S
• Device Lot Number: 8L14163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: DISTAL RADIUS; UNK - SCREWS: DISTAL RADIUS
• Patient Age: 49 YR