MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: DHS/DCS; APPLIANCE, FIXATION, NAIL

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

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Ambulation Difficulties (2544)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown constructs: dhs/dcs/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.

Event Description

This report is being filed after the review of the following journal article: betegón c., et al (2020) fractures in patients with poliomyelitis: past or current challenge?, injury volume 51,supplement 1, pages s48¿s54 (spain) https://doi.Org/10.1016/j.Injury.2020.02.029.This retrospective study aims to to analyze epidemiological parameters, fracture¿s morphology and location, type of treatment (be conservative or surgical) and implant used, as well as the evolution and long-term functional outcome of patients with poliomyelitis who suffered fractures in the poliomyelitis-affected lower limb.Between 1977 and 2016,62 patients with mean age at the time of fracture was 61.7 years (38¿93) who suffered a fracture in a lower limb previously affected by polio, and that were treated were included in this study.Of all the fractures studied in our series:proximal femur fractures, femoral shaft fractures, distal femur fractures, isolated fractures of the femoral condyle, tibial plateau fractures, proximal tibial metaphysis fractures, tibial shaft fractures, patellar fractures, ankle fractures, tibial pilon fractures, 85.1% were treated surgically, while 14.9% were managed nonsurgically.For pertrochanteric fractures 15 cases, in non-polio patients, the usual treatment is the endomedullary nailing.In the group of intertrochanteric fractures with a mean age of 64.4 years, the gamma nail was used; the dhs plate in 20%; ender nails at 6.7% and lcp plate at 6.7%.For persubtrochanteric fractures 4 cases with mean age of 68.8 years,for non polio patients usually treated endomedullary nailing with long gamma nail and two patients with dhs plates.For tibial diaphyseal fractures 10 cases with mean age in our series was 59.5 years.Among these total 10 cases, 1 was treated with by nailing with a multiloc (®depuy synthes) nail of humerus.The mean follow-up was 20.2 months.The following complications were reported as follows: fig.2.A case of a male patient who had a tibial shaft fracture treated conservatively initially that, as a result of a new trauma, broke again through the weak fracture¿s callus.The limb was very displasic, with a narrow endomedular canal.Therefore it was decided to nail using a narrower nail, a humerus multiloc (®depuy synthes) nail.During the admission he did not present any incidence but died before the first review after a massive heart attack.The second of the deceased cases was a male patient who suffered a patella fracture and usually treated with tension band wiring or conservatively and who was then diagnosed of stage iv lung cancer with multiple metastases and died during admission.Radiological consolidation was observed in all cases that were followed in our center, although 20.3% of them presented delayed consolidation (more than 6 months).There was no evidence of pseudoarthrosis.For pertrochanteric fractures: 6.7% of the patients required removal of osteosynthesis material and 6.7% presented some type of complication (a case that presented fever of unknown origin that was resolved with empirical antibiotic cover- age).For persubtrochanteric fractures: two experienced a total loss of deambulation ability.For tibial diaphyseal fractures: seven (70%) suffered deterioration with the need to increase mechanical aids.This report is for an unknown synthes dhs, lcp and multiloc nail of humerus.This report is for one (1) unk - constructs: dhs/dcs.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: DHS/DCS
• Type of Device: APPLIANCE, FIXATION, NAIL
• 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: 11454820
• MDR Text Key: 246978688
• Report Number: 8030965-2021-01804
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/10/2021
• 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