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

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: poelmann, j.And kloean, p.(2021), modified use of the proximal humeral internal locking system (philos) plate for distal femoral nonunions, european journal of orthopaedic surgery & traumatology, vol.Xx pages 1-9, (netherlands).The aim of our study was to report our results after use of a minimally invasively placed proximal humeral internal locking system (philos) plate as a medial buttress in the treatment of a distal femoral nonunion.A total of 15 patients (9 females and 6 males) with a median age of 68 (range 19¿81) underwent surgery for a dfn using the philos plate as a medial buttress between november 2013 and october 2019.Initial surgery was done for distal femoral fractures using a liss plate, dcs, and a lateral lcp.Median follow-up was 24 months (range 3¿56).The following complications were reported as follows: 1 patient died.Patient 2: a (b)(6) male patient was treated with a liss plate which was revised to an ncb plate + allograft bone chips.The patient also had nonunion which was treated with 95-degree condylar blade plate + medial philos plate.Patient 3: a (b)(6) male patient was treated with a lateral lcp which was revised to bone grafting with 2 allograft femoral heads (1), medial distal femur plate + right icbg + femoral head (2), removal of loose screws (3).The patient also had nonunion which was treated with 95-degree condylar blade plate + medial philos plate.Patient 4: a (b)(6) male patient was treated with a liss plate which was revised to an incision + drainage (1,2), lateral va distal femur lcp + anterior lcp + icbg + dbx (3), incision + drainage (4), anterior plate removal + gentabeads (5), removal of gentabeads + antibiotic cement coated liss plate (6), debridement + antibiotic cement coated liss plate (7).The patient also had nonunion which was treated with va distal femur lcp + medial philos plate.Patient 5.A (b)(6) male patient had nonunion after dcs.Nonunion was treated with liss plate + medial philos plate.Patient 6: a (b)(6) male patient was treated with a liss plate which was revised to an which was revised to a va distal femur lcp + fibula allograft + dbx.The patient also had nonunion which was treated with 95-degree condylar blade plate + medial philos plate.Patient 7: a (b)(6) male patient was treated with a liss plate which was revised to a 95-degree condylar blade plate + icbg.The patient also had nonunion which was treated with 95-degree condylar blade plate + medial philos plate.Patient 8: a (b)(6) female patient was treated with a liss plate which was revised to a 95-degree condylar blade plate + icbg.The patient also had nonunion which was treated with va distal femur lcp + medial philos plate.Patient 9: a (b)(6) female patient was treated with a lateral lcp + calciumphosphate which was revised to a 95-degree condylar blade plate + icbg + dbx.The patient also had nonunion which was treated with va distal femur lcp + medial philos plate.Patient 10: a (b)(6) female patient had nonunion after va distal femur lcp treatment.Nonunion was treated with va distal femur lcp + medial philos plate.Patient 11: a (b)(6) female patient was treated with a lateral lcp + homologous bone graft which was revised to an allograft croutons (1), icbg (2), + quadriceps release (3), 95-degree condylar blade plate + icbg (4), 95-degree condylar blade plate + icbg + dbx (5).The patient also had nonunion which was treated with a medial philos plate.Patient 14: a (b)(6) female patient was treated with a liss plate which was revised to a liss plate + cerclage around prosthesis (1), reposition liss plate (2), croutons + icbg (3).The patient had second revision due to maplosttion of liss plate.The patient also had persistent nonunion.3 patients needed additional surgeries to procure healing.Two received surgeries at respectively 2 and 6.5 months after the index operation.One patient received additional posterior icbg and united after 9 months.The second patient also received posterior icbg with addition of three cancellous screws and united 2 months later.1 patient underwent a judet quadricepsplasty for a stiff knee (arc of motion 30 degrees) one month after union was confirmed.3 patients presented with a broken plate.This report is for an unknown synthes liss plate/screws construct.This report captures the reported (b)(6) male patient who was revised to an incision + drainage (1,2), lateral va distal femur lcp + anterior lcp + icbg + dbx (3), incision + drainage (4), anterior plate removal + gentabeads (5), removal of gentabeads + antibiotic cement coated liss plate (6), debridement + antibiotic cement coated liss plate (7).The patient alos had nonunion which was treated with va distal femur lcp + medial philos plate.A copy of the literature article is being submitted with this report.This is report 3 of 15 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown constructs: liss plate/screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 - CONSTRUCTS: LISS PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14428285
• MDR Text Key: 291941508
• Report Number: 8030965-2022-03259
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,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: 05/18/2022
• 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: 05/02/2022
• 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
• Patient Age: 40 YR
• Patient Sex: Male