MAUDE Adverse Event Report: SYNTHES GMBH UNK - GUIDE/COMPRESSION/K-WIRES; WIRE, SURGICAL

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

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2020

Event Type  Injury  

Event Description

It was reported that on or about (b)(6) 2019, the patient suffered a fall and was implanted with 4.5 mm proximal tibial plate and synthes screws.On or about (b)(6) 2020, patient developed infection and was treated and hospitalized.On or about (b)(6) 2020, x-ray was taken of the left lower extremity which revealed acute fracture in the 4.5 mm proximal tibial plate.On or about (b)(6) 2020 patient underwent revision surgery to remove the defective fractured 4.5 mm proximal tibial plate and other associated screws.This pc created to capture the event of patient's infection.This report involves one unk - guide/compression/k-wires.This is report 2 of 4 for (b)(4).This pc is related to the following pcs: (b)(4) reports infection (additional devices).(b)(4) reports implant breakage.

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.Event date: only the event month and year are known.This report is for an unknown guide/compression/k-wires/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

• Brand Name: UNK - GUIDE/COMPRESSION/K-WIRES
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16417772
• MDR Text Key: 309976277
• Report Number: 8030965-2023-02118
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2023
• 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
• Treatment: 4.5 LCP PROXIMAL TIB PL 12H/226/LFT-S; 4.5MM CORTEX SCREW SELF-TAPPING 28MM; 4.5MM TI CORTEX SCREW SELF-TAPPING 26MM; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 26; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 55; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 60; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 60; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 60; 5.0MM CANNULATED CONICAL SCREW 80MM; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDE/COMPRESSION/K-WIRES
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female