MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PHILOS PLATE/SCREWS; SCREW,FIXATION,BONE

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

Patient Problems Wound Dehiscence (1154); Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - constructs: philos plate/ screws/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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: park, k.-h.Et al (2021), excellent outcomes after double-locked plating in very low periprosthetic distal femoral fractures, archives of orthopedic and trauma surgery, vol.141 (xx), pages 207¿214 (korea, south).The aim of this retrospective study is to evaluate the double-plating technique through the lateral mi approach and medial subvastus approach in su type iii ppdffs.Between january 2013 to december 2018, a total of 21 patients (4 male and 17 female) with a mean age of 76 years (range 56¿90) were treated with double-plating technique through the lateral mi and medial subvastus approaches.In the lateral mi approach, a pre-shaped locking compression plate-distal femur (lcp-df; depuy synthes®, zuchwil, switzerland) was fixed using the mi plate osteosynthesis technique.In the medial subvastus approach, various types of locking plates were fixed, with careful handling of soft tissue.The medial plates were used on the medial cortices with an lcp lowbend medial distal tibia plate (depuy synthes®) in 14 cases, a proximal humeral internal locking system plate (philos, depuy synthes®) in five cases, and a narrow lcp (depuy synthes®) in two cases.The following complications were reported: a (b)(6) year-old man had a nonunion at 11 months postoperatively.While the lateral plate was fixed in stable, screw breakage and loosening from the medial plate were progressively observed, without healing of the fracture.Severe comminution and insufficient numbers of proximal screws at the medial aspect are attributed to this nonunion.Osteosynthesis was performed, with changing the previous philos plate into an lcp low-bend medial distal tibia plate and addition of autogenous bone graft.It successfully healed at 6 months.4 patients had complication in soft tissue healing, which occurred at the incision of the medial approach.3 of which had superficial infection, which healed after administration of oral antibiotics.An (b)(6) year-old woman who had uncontrolled diabetes mellitus and an atherosclerotic vascular lesion showed wound dehiscence.There was progression to sepsis due to deterioration of femoral artery occlusion and systemic condition, and no further surgery was possible.This report is for an unknown synthes philos plate, unknown synthes philos screws, unknown synthes lcp distal femur plate/screws constructs, unknown philos plate/screws constructs, unknown synthes lcp lowbend medial distal tibia plate/screws constructs, and unknown synthes narrow lcp constructs.This report is for (1) unk - constructs: philos plate/screws.This report is 3 of 11 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PHILOS PLATE/SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12338488
• MDR Text Key: 267157422
• Report Number: 8030965-2021-06788
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• 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
• Patient Outcome(s): Required Intervention