MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LCP HOOK PLATE 3 HOLE; PLATE, FIXATION, BONE

Model Number	02.113.103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	01/01/2022
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.Additional narrative: only the event year is known.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 or Problem Description
It was reported that on an unknown date, the patient underwent open reduction/internal fixation for a right bimalleolar ankle fracture with repair of syndesmosis.Four weeks post op, patient had a 1mm opening in the midportion of the medial excision with clear, serosanguinous discharge with no erythema.A 10-day course of augmentin was administered to the patient.6 weeks post op, 1mm opening had widened and a screw head had become visible.Under sterile conditions, the screw head was removed in office, with wound irrigation and closure.Patient was continued on augmentin for infection prophylaxis.For the remainder of the follow up, patient demonstrated excellent rehabilitation, pain control, and no signs of infection.This report involves one 3.5mm lcp hook plate 3 hole.This is report 1 of 6 for (b)(4).

• Brand Name: 3.5MM LCP HOOK PLATE 3 HOLE
• 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: 15638920
• Report Number: 8030965-2022-08469
• Device Sequence Number: 12232861
• Product Code: HRS
• UDI-Device Identifier: 10886982034724
• UDI-Public: 10886982034724
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• 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 Model Number: 02.113.103
• Device Catalogue Number: 02.113.103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown