MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7MM TI LOCKING TALUS PLATE; PLATE, FIXATION, BONE

Catalog Number	04.100.023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/27/2023
Type of Reportable Event	Serious Injury
Additional 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 not expected to be returned for manufacturer review/investigation.D10: date of concomitant therapy is (b)(6) 2022.H3, h6: 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.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part # 04.100.023; synthes lot # 7494089; supplier lot # n/a; release to warehouse date: (b)(6) 2013; manufactured by: synthes elmira; no ncrs were generated during production.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 or Problem Description
Device report from brazil reports an event as follows: it was reported that the patient underwent an unknown procedure on (b)(6) 2022 in which the products in question were implanted.The patient has been presenting with a reaction at the site of the procedure for over 1 year.Products have not been explanted.No further information is available at this time.This report is for a 2.4/2.7mm ti locking talus plate.This is report 1 of 5 for (b)(4).

• Brand Name: 2.4/2.7MM TI LOCKING TALUS PLATE
• Common Device Name: 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: 17424255
• Report Number: 8030965-2023-09539
• Device Sequence Number: 17622812
• Product Code: HRS
• UDI-Device Identifier: 10886982099488
• UDI-Public: (01)10886982099488
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K071264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.100.023
• Device Lot Number: 7494089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE Ø1.1 L150 SST.; HCS Ø2.4 SELF-DRILL CANN L20/4 TAN.; LOCKSCR Ø2.4 SELF-TAP L18 TAN.; TALUSPL 2.4 LOCKING TI.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female