MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM LCP POSTLAT DSTL FIBULA PL 4H/LEFT/90MM-STER; PLATE, FIXATION, BONE

Catalog Number	02.112.109S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Impaired Healing (2378)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date, the patient underwent surgery to fracture repair of an open, displaced, complex (comminuted) fracture of the distal tibia on the right side using two 3.5mm headed titanium screws 42mm long with long thread with supplemental fixation using a depuy synthes 2.4mm variable angle lcp dorsal distal radius t-plate with a 3-hole head and a 5-hole shaft (51mm long, stainless steel).Subject also underwent a fracture repair of the fibula and received a depuy synthes 2.7mm/3.5mm lcp posterolateral distal fibula plate (4 holes, 90mm in length, left orientation, made of stainless steel).Operating room time was 60 minutes.Post-operative treatment: bracing/immobilization: non weight bearing for 10 weeks, partial weight bearing until 12 weeks post op in a boot, full weight bearing in a gym shoe at 12 weeks post op; at 4.5 months post-operative patient had hardware removal and was instructed to weightbear as tolerated; pain medication: hydrocodone acetaminophen (5-325mg taken every 4 hrs or as needed for 2 months), clindamycin (300mg 3x/day for 10 days starting 4 weeks post-operative) to prevent infection.Was taking gabapentin (400mg once daily for seizure disorder) pre-operatively subject compliant with post-operative treatment the subject had an adverse event 4 weeks post-operatively.The patient was placed on clindamycin (300mg 3x/day for 10 days due to history of diabetes and open ulcerations.The event was intermittent, moderate, serious, not life threatening, and unanticipated.The actions taken for this event required therapy and the patient recovered with sequelae.After the clindamycin was discontinued, the patient was managed by wound care team for additional follow up and wound treatment.The patient had a second visit with her orthopedic surgeon because her wound did not heal with the assistance of the wound care team.The patient was subsequently brought back to the or in an outpatient hospital setting on (b)(6) 2023 (4.5 months post-operative) for removal of all hardware (both plates and both headed screws), incision and drainage, and application of a wound vac.The patient had a picc line placed with a course of antibiotics due to nonhealing of the wound and concern of possible osteomyelitis.Following hardware removal, the wound granulated and there was no need for additional surgical intervention.The patient continued to follow-up with wound care after discharge from the hardware removal surgery and was instructed to follow up with her orthopedic surgeon as needed or as directed by wound care.No additional follow ups were required.The patient recovered without sequalae.Subject returned to normal activity 10 months after surgery (with complete wound healing and no remaining infection) at 3 months post-operative, the subject was radiographically fused, however the infection remained present.At 4.5 months post-operative, the subject¿s hardware was removed to address wound healing complications.At 10 months post-operative, the subject was satisfied and would probably have the treatment again if recommended at 10 months post-operative, the patient had a vas pain score of 20.At 10 months post-operative, by sf-36, the subject reported 75% for physical functioning, 100% for limitations to physical health, 100% for limitations to emotional health, 80% for energy/fatigue, 80% for emotional well-being, 75% for social functioning, 77.5% for pain, and 45% for general health.
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.H11 additional narrative: d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.7MM/3.5MM LCP POSTLAT DSTL FIBULA PL 4H/LEFT/90MM-STER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• 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: 20223358
• Report Number: 8030965-2024-11494
• Device Sequence Number: 7328258
• Product Code: HRS
• UDI-Device Identifier: 10886982033406
• UDI-Public: (01)10886982033406
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• 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 Catalogue Number: 02.112.109S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5MM TI CANN SCREW + LT - 42MM; 3.5MM TI CANN SCREW + LT - 42MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female