MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM SPRING PLATE/2 HOLES; PLATE, FIXATION, BONE

Catalog Number 02.100.302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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.E3: reporter is a synthes employee.H3, h6: part: 02.100m302sp.Lot: 162p563.Part manufacture date: 21 may 2021.Manufacturing location: elmira.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm spring plate 2 holes-sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot was shipped to monument for final packaging.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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.

Event Description

Thayer school of engineering at dartmouth data for q3 and q4 2023.A depuy synthes implant was revised and reviewed for analysis.Reason for revision: "other infection".This report is for a 3.5mm spring plate/2 holes.This report is 4 of 10 for (b)(4).

• Brand Name: 3.5MM SPRING PLATE/2 HOLES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14846
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18989328
• MDR Text Key: 338738823
• Report Number: 8030965-2024-04162
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982028723
• UDI-Public: (01)10886982028723
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 02.100.302
• Device Lot Number: 162P563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention